Taking Care of Us (TCU) Study Protocol: A Dyadic Intervention for Couples Living with Heart Failure

doi:10.21203/rs.3.rs-1428012/v1

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Research Article

Taking Care of Us (TCU) Study Protocol: A Dyadic Intervention for Couples Living with Heart Failure

https://doi.org/10.21203/rs.3.rs-1428012/v1

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published 25 Jan, 2023

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Background: There are more than 1 million hospital admissions and 3 million emergency visits for heart failure in the U.S. annually. Although spouse/partners make substantial contributions to the management of heart failure and experience poor health and high levels of care strain, they are rarely the focus of heart failure interventions. This protocol describes a pilot randomized controlled trial that tests the feasibility, acceptability, and preliminary efficacy of a seven-session couple-based intervention called Taking Care of Us (TCU). The TCU intervention is grounded in the Theory of Dyadic Illness Management and was developed to promote collaborative illness management and better physical and mental health of adults with heart failure and their partners.

Methods: A two-arm randomized controlled trial will be conducted. Eligible adults with heart failure and their co-residing spouse/partner will be recruited from a clinical site in the USA and community/social media outreach and randomized to either the TCU intervention or to a control condition (SUPPORT) that offers education around heart failure management. The target sample is 72 couples (36 per arm). TCU couples will receive seven sessions over two months via Zoom; SUPPORT couples will receive three sessions over two months via Zoom. All participants will complete self-report measures at baseline (T1), post-treatment (T2), and 3 months post-treatment (T3). Acceptability and feasibility of the intervention will be examined using both closed-ended and open-ended questions as well as enrollment and retention metrics. Preliminary efficacy of TCU on dyadic health, dyadic appraisal, and collaborative management will be examined using standardized measures.

Discussion: Theoretically-driven, evidence-based dyadic interventions are needed to optimize the health of both members of the couple living with heart failure. Results from this study will provide important information about recruitment and retention and benefits and drawbacks of the TCU program to directly inform a large-scale grant application to test the impact of the TCU program in a fully powered sample.

Trial registration: ClinicalTrials.gov (NCT04737759) registered on 27 January 2021.

Heart failure

couples

dyadic health

communication

collaboration

confidence

support

physical health

mental health

Zoom-based

Heart failure is the fastest growing cardiovascular disorder in the U.S., and most common reason for both hospitalization and rehospitalization among older adults (1, 2). Adults with heart failure experience severe symptom burden, significant functional limitations, and poor quality of life (3, 4). Although family care partners (e.g., spouse or adult-child) make substantial contributions to the management of heart failure (5), experience poor health themselves (6) and significant care strain (7), they are rarely the focus of heart failure interventions (8–10). Thus, there is great need for novel theoretically-informed interventions targeted at the heart failure dyad (i.e., adult with heart failure and their care partner) to reduce the family burden of heart failure (11–13).

Heart failure is a clinical diagnosis based on a history of symptoms and physical examination (14). Adults with heart failure experience considerable variability in symptoms and changes in symptoms are the primary reason why adults with heart failure seek treatment (15, 16). Thus, symptoms are critical elements of the diagnosis, management and the lived-experience of heart failure for both the person with the illness and also their care partner. The continual need for symptoms to be managed place considerable demands on heart failure care dyads, resulting in poor physical and mental health for both members (17–22).

Most non-pharmacologic heart failure interventions involve patient education and behavioral counseling, with limited success (10, 23). Potential reasons for lack of efficacy include a focus on adherence behaviors, interventions that do not include family members or care partners, and failure to acknowledge the interpersonal context of illness (24, 25). Similarly, 50% of the small number of heart failure interventions targeting the care partner did not improve outcomes (8). Within the broader chronic illness literature, dyad-based interventions have been found to be more successful than individual interventions (26, 27). Yet, despite recent movement to involve care partners in heart failure interventions (28), the focus has been predominantly on adherence behaviors and education, demonstrating inconsistent efficacy on outcomes for the dyad (10). A review of interventions in coronary artery disease dyads highlighted the effectiveness of targeting psychosocial variables (29), with communication and positive interpersonal dynamics considered essential for improving the outcomes of both the adult with heart failure and their care partner (24, 25, 28).

Across illness contexts, there is strong evidence of the interdependent nature of the experience within couples and the important roles of support and a sense of “we-ness” (30–36). Building on this salient work and the fields of illness management and caregiving, the guiding theory for the Taking Care of Us (TCU) program, the Theory of Dyadic Illness Management (31), focuses on the couple as the unit of interest with the main goal to optimize health within the couple by balancing the needs of both members. The theory proposes that couples who have shared appraisal about the illness experience (e.g., similar appraisals of the person with heart failure’s symptoms) are more likely to engage in dyadic illness management behaviors (e.g., collaborative symptom management behaviors, open communication about the illness, shared health activities). Dyadic management encompasses the spectrum of how couples collaborate, communicate and feel confident around management of the illness. Greater shared appraisal and engagement in dyadic management behaviors lead to better physical and mental health of both members of the couple. Thus, TCU focuses on the concepts of dyadic symptom appraisal, dyadic management behaviors and dyadic health.

Shared dyadic appraisal is vital to the effective management of heart failure within couples (37). Studies have found moderate gaps in appraisal of heart failure symptoms within the couple (38–40), which has been associated with inadequate illness management, lower levels of collaboration and poor outcomes (41–44). Yet, no intervention has targeted symptom appraisal within the context of the couple. Similarly, research has found collaborative verbal and non-verbal behaviors to manage symptoms and illness are associated with better health outcomes (45–49), with emerging evidence in heart failure (19, 50–52). Finally, confidence (self-efficacy) plays an important role in health behavior change (53) and is a defining characteristic of self-management programs (54, 55). Within heart failure, confidence has been associated with greater engagement in management behaviors and better health outcomes for the adult with heart failure and care partner (56–63). Yet, few heart failure studies have examined confidence of both members of the couple or capitalized on the known social context of confidence (62).

To address these gaps, we designed a theoretically-informed and evidence-based dyadic intervention for adults with heart failure and their spouse/partner, Taking Care of Us (Fig. 1). The aims of this pilot study were to 1) evaluate the preliminary efficacy of the intervention on dyadic health (i.e., global health, depressive symptoms, anxiety and healthcare utilization), 2) evaluate the preliminary efficacy of the intervention on dyadic symptom appraisal (i.e., pain, dyspnea, fatigue), dyadic management behaviors (i.e., collaborative symptom management, collaborative coping behaviors and communication) and confidence to manage heart failure, and 3) determine feasibility and acceptability of the intervention to inform larger trials.

Design

This is a two-arm, pilot randomized controlled trial comparing the TCU program with an educational counseling attention-control condition, SUPPORT. A target of 72 couples will be enrolled in the study, which allows for 17% attrition to achieve a complete sample of 60 couples. Couples will be randomized to either TCU or SUPPORT, with equal allocation. Block randomization stratifying by gender of the adult with heart failure will be created by MPI CSL using an online research randomizer (www. randomizer.org). We will stratify by gender to maximize equal distribution between the two conditions. Both programs span two months in length and are delivered by trained interventionists to the couple via Zoom. All participants will be assessed at baseline (T1), post-treatment (T2), and 3 months post-treatment (T3) using separate self-report web-based measures. The study design is guided by the Consolidated Standards of Reporting Trials (CONSORT) extension criteria for pilot and feasibility trials (64) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines – a SPIRIT checklist was completed (65). The SPIRIT flow diagram of the trial is presented in Fig. 2. Patient recruitment and data collection began in July 2021 and is currently ongoing.

Participants

Adults with heart failure are eligible to participate if they self-report a diagnosis of heart failure as an adult; currently experience heart failure symptoms or have been told they are NYHA Class II or III or AHA/ACC Stage C; are at least 18 years of age; have a spouse or partner they have lived with for at least six months that is willing and eligible to participate in the study; and have access to a device with a camera (e.g., computer, tablet) to participate in Zoom sessions, or a phone to participate in phone sessions. Partners (the term partner is used throughout the study to refer to both spouses and intimate partners) are eligible to participate in the study if they are also at least eighteen years of age and have lived with the adult with heart failure for at least six months.

Couples are excluded if either member: has major uncorrected hearing impairment; has significant cognitive impairment; is enrolled in another intervention trial that would prevent them from completing the requirements of this study; has active psychosis or severe substance abuse that would impair their ability to complete the study. Couples will also be excluded if the adult with heart failure has had a heart transplantation; is in receipt of a mechanical circulatory support device; or has another terminal illness that would prevent them from participating in a five-month study. Couples are not required to be married and no couples will be excluded based on sexuality or gender identity.

Recruitment And Data Collection Procedures

Couples are recruited through the Tufts Medical Center Heart Failure clinic, Boston, Massachusetts, and also through community outreach locally (e.g., local newspapers, councils on aging, newsletters) and nationally via clinical partners in cardiology clinics, websites (e.g. Family Caregiver Alliance) and social media (e.g. Facebook). Study investigators at Tufts Medical Center will communicate with eligible patients in their heart failure clinic about the study and provide them with the study recruitment materials that include the study phone number at Boston College and QR code managed by the study research team at Boston College. Interested participants contact the Boston College study team either by phone or the QR code and are screened for eligibility by phone. Similarly, our community outreach recruitment involves distributing information through media, social media and presentations, and interested participants are provided information to call, email, or use the QR code to contact the Boston College study team for more information and/or to schedule a time for a phone eligibility screening. Eligible and interested couples are e-mailed separate links to provide consent using a web-based survey, though participants are provided the option to complete paper versions of the consent form by mail. Couples are considered to be formally enrolled and consented when electronic or written consent forms are completed by both members of the couple.

Participants complete three surveys over the course of the study at baseline, month 2 (post-treatment), and month 5 (three months post-treatment). Adults with heart failure and their partners complete separate surveys. Participants can complete the surveys either by Research Electronic Data Capture (REDCap) – a HIPAA-compliant, secure, web-based application – or by mail survey. This allows participants to have greater choice for their preferred mode, which increases both recruitment and retention across the adult lifespan. In rare circumstances we will also provide a phone interview to complete the survey. All participating couples will be assigned a code number and all identifying information will be removed from all data sources (electronic and hard copy). All study data will be stored in a secure, password-protected network folder on the Boston College server. Data from mail surveys will be entered and verified by trained research staff before merging with data obtained via REDCap. Due to minimal risk of the study, MPIs are responsible for data monitoring.

Upon completing the baseline survey, couples are randomized by the project coordinator to either the TCU arm or the SUPPORT arm and receive a phone call from their assigned interventionist to inform them of their assigned program and to schedule the first session. Upon completion of the study, couples receive a $100 gift card. In cases where one or both members of the couple cannot or does not want to continue participating in their assigned program (TCU or SUPPORT), either member of the couple may still choose to complete follow-up data assessments, at approximately two and five months post-baseline. However, participants cannot continue in their assigned program as individuals (they must complete the program together).

Intervention Group

Taking Care of Us is a theoretically and empirically informed intervention that is communication-based and relationship-focused, building on the strengths of the couple while fostering new skills. Drawing upon our theory of dyadic illness management (31), previous research, and key components of successful dyadic and self-management interventions, the goals of the seven session program are to improve shared symptom appraisal and dyadic management by fostering communication, collaboration and confidence within the couple, thereby leading to better dyadic health. The sessions are designed to encourage participants to reflect on their strengths and areas of challenge as a couple and to rephrase their goals from individual to dyadic. Throughout the sessions, the interventionist works with the couple and facilitates communication and problem-solving to reach shared goals and strategies that balance the health and needs of both members. Tools are used to summarize and enhance discussions and agreed-upon strategies and goals. Each of the seven sessions last approximately 45–60 minutes and take place by zoom or phone. Sessions occur approximately once a week starting approximately one week after the baseline surveys are complete (the entire program is approximately two months in length).

Content builds throughout the program and is tailored to the area couples agree to work on together, reflecting a respect for each couple’s readiness to change. Early on the importance of respectful and supportive communication is introduced with specific skills the couple can practice. Strong emphasis is placed on speaker-listener techniques so that members of the couple can share and hear in a facilitated context. The program also places emphasis on the social aspect of confidence and role of supporting one another in increasing confidence as a team. Because the program is strengths-based, it provides couples with skills, confidence and knowledge to collaborate and support one another, and communicate with each other to balance their respective health needs and take a team approach to living with heart failure. Couples will practice skills and try out simple strategies between sessions and then reflect on how things went with the interventionist and each other to brainstorm when changes would help. The goal of such exercises is to encourage the couple to practice skills learned in sessions and demonstrate the manageable way goals can be broken down into small and simple strategies. Successful strategies will be noted and combined with a shared collaborative plan the couple creates during the sessions that will be sent to the couple on completion of the program. The seven sessions and their content and format are presented in Table 1.

Table 1

Taking Care of Us Intervention Session Overview
Session	Session Title	Session Outline
1	A Couple-Based Approach to Heart Failure	• Overview of the Taking Care of Us program • Overview of the importance of heart failure symptom management • Working as a team through communication
2	How are we doing?	• The positive roles of communication, collaboration and confidence • Engaging in self-management activities.
3	Living with Heart Failure Part I	• Communicating about heart failure symptoms • Recognizing heart failure symptoms
4	Living with Heart Failure Part II	• Collaboration and support. • Shared goals for working together.
5	Supporting Care Partner Health	• Care partner health and needs • Supporting the care partner
6	Strengthening our Relationship	• Strengthening our relationship: fun activities, closeness, physical intimacy
7	Putting it all together	• Creating a long-term plan • Staying flexible • Involving healthcare providers and other family/support

Each couple will receive a Taking Care of Us binder with materials to accompany each session (i.e., resource pages summarizing the theme of each session, worksheets to facilitate in-session activities related to each session’s theme, and home practice activities). The binder also includes local and national resources that may be helpful (e.g., heart failure, mental health, disability, financial, caregiving, housing, food).

Control Group

The SUPPORT program is an attention-control condition and comprises of three sessions that occur approximately 1, 4 and 8 weeks after the baseline survey is completed (the program is also approximately two months in length to match the intervention exposure period). Each session is 45–60 minutes in length and takes place via Zoom or phone. The program is an educational counseling program similar to heart failure educational interventions currently available and is, therefore, a more realistic comparison condition than “usual care.” Session 1 overlaps with the first session of TCU by focusing on heart failure symptoms and self-care of heart failure. Session 2 focuses on healthy eating, and session 3 focuses on physical activity. All sessions are designed to facilitate reflection and preliminary action planning and focus primarily on the person with heart failure (though the partner is required to be present in all sessions). Materials represent current clinical practice guidelines and publicly-available educational information developed by the Heart Failure Society of America and the American College of Sport Medicine. Thus, the program is considered reproducible. Each couple will receive a SUPPORT binder with materials to accompany each session (i.e., resource pages summarizing the theme of each session). The binder also includes the same local and national resources provided to the TCU group (e.g., heart failure, mental health, disability, financial, caregiving, housing, food).

Interventionists

Both programs are delivered by interventionists with a bachelor’s or master’s degree in mental health. Interventionists were trained by the study MPIs through a series of in-depth sessions guided primarily by the TCU intervention manual and SUPPORT manual, which both contain overviews of the program and philosophy, guiding principles, scripts for each session, session materials, tips for dealing with challenging scenarios, and reporting adverse events or safety concerns. Additionally, interventionists were provided with key background readings on heart failure, caregiving, and a dyadic approach to illness including the theoretical framework underpinning the intervention. Training sessions focused on the elements of the training manual mentioned above, the goals of each session, role-playing, dealing with challenging scenarios (i.e., disagreement and conflict) and confidentiality and safety. Over time, interventionists continue to be supervised with sessions reviewed and debriefed regularly. Interventionists are trained to deliver both programs to avoid unnecessary interventionist effects.

Safety

All members of the team receive training on reporting adverse events or safety concerns to the MPIs promptly. Each member also received a research training manual outlining all elements of the research protocol. Given the minimal risk of the study, a safety monitoring committee consisting of both MPIs and two leading researchers in the fields of heart failure and caregiving research was formed to oversee and monitor any safety concerns or adverse events that might arise during the study. All adverse events will be promptly reported to the Boston College IRB and funding agency.

Fidelity

Treatment fidelity in the current study is maximized through the use of clear protocols and manuals that are scripted, ongoing training and supervision throughout the study, and fidelity checks. Fidelity checks include the use of adherence checklists that are completed at the end of every session by the interventionists to document whether key components of the session were adhered to. Session summary sheets are also completed at the end of each session, by the interventionists, to document the engagement of the couple, any challenges encountered in delivering the content, and their role as facilitator. These checklists and summary sheets provide a basis for ongoing training and supervision. Finally, sessions are recorded at random throughout the study and viewed by the principal investigators, who also complete a fidelity checklist that key components of the session were covered and document any feedback given. Couples will have the option of opting out of the possibility of being selected to have a session recorded for fidelity purposes. When a session is selected and the couple agrees to the recording, the session is viewed by the principal investigators within three days and then destroyed.

Measures

The aims of the current study will examine dyadic and individual health of the couple, dyadic symptom appraisal, dyadic management and acceptability and feasibility of the program.

Health

The psychometrically-sound 10-item PROMIS Global Health short form (66) will be used as a general measure of QOL for couples. The measure includes specific ratings of physical, mental and overall QOL. Depressive symptoms will be measured using the reliable and valid Center for Epidemiological Studies-Depression (CES-D) scale (67). The scale asks participants to respond to 20 items regarding how they felt over the past week (e.g., I felt depressed) on a 0 (rarely or none of the time) to 3 (most or all the time) scale. Items are summed to create a total score (range from 0–60), with higher scores indicating greater depressive symptomology. Anxiety will be measured using the psychometrically-sound Brief Symptom Inventory (BSI) subscale (68). Participants are asked about feelings during the past seven days and provides five response options ranging from 0 (not at all) to 4 (extremely). The Stanford Patient Education Research Center (PERC) Healthcare Utilization is a reliable and valid assessment of healthcare use that will be administered at baseline and T3 to collect physician, mental health, emergency room visits and hospitalizations for both members of the couple (69). The Multidimensional Caregiver Strain Index (70) is a highly reliable measure of physical, social and interpersonal strain, time constraints and demands for partners that will be administered at each wave. The Kansas City Cardiomyopathy Questionnaire, a psychometrically sound 12-item Likert scale, will be used to measure heart failure-specific quality-of-life for adults with heart failure. Scores range from 0-100 with higher scores reflecting better QOL (71–73).

Dyadic Appraisal

The couple’s appraisal of heart failure symptoms (i.e., dyspnea, pain, fatigue) will be assessed at all waves using well-established, reliable and valid measures. Dyspnea will be measured with the 6-item dyspnea subscale of the Heart Failure Somatic Perception Scale (74). The scale asks about how much the adult with heart failure was bothered by dyspnea during the last week on a 0 (not at all) to 5 (extremely bothersome) scale (75). Pain Interference will be measured using the 6-item PROMIS pain interference scale (76). Fatigue will be measured using the 8-item PROMIS fatigue scale (77–79). Dyadic appraisal scores for each symptom will be calculated using multilevel modeling (see analysis plan below).

Dyadic Management

Dyadic management is a broad concept that captures the verbal and non-verbal strategies that help dyads manage and cope with illness (31, 80). In the current trial we focus on three aspects of dyadic management – communication, collaboration, and confidence to manage heart failure.

Communication within the dyad will be examined using the Dyadic Coping measure, which consists of two subscales (active engagement and protective buffering) (81, 82). Active engagement assesses the extent to which the person views their partner’s active involvement and support (81, 82). Participants respond to five items using a Likert scale from 1 (never) to 5 (very often). Protective buffering assesses the extent to which the person views their partner’s use of hiding concerns and denying worries (81, 82). Participants respond to six items using a Likert scale from 1 (never) to 5 (very often). Both scales have demonstrated reliability and validity (82).

Collaboration will be examined through both individual and shared engagement in managing heart failure and engagement in dyadic coping behaviors. Couple engagement in heart failure management will be measured using the management scores of the Self-Care of HF Index v6.2 (SCHFI) (83). The SCHFI has 6 items that capture management. Response options range from 1 (not likely) to 4 (very likely). Scores are standardized to 0-100 with higher scores indicating greater engagement. In addition, couples will be asked to rate how much they collaborate regarding management of heart failure using the revised Stanford Chronic Disease Self-Management measure (84). Couples are asked to rate their level of collaboration around six aspects of the illness (e.g., fatigue, emotional distress) on a 0 (no collaboration) to 10 (a great deal of collaboration) scale. A summary score is created by calculating the mean collaboration level across the six items. Finally, the common dyadic coping subscale from the well-established and validated Dyadic Coping Inventory (85) will measure how much couples engage in collaborative coping. Participants respond to items (e.g., joint problem-solving, communication) on a 1 (very rarely) to 5 (very often) scale.

Confidence

Finally, confidence to manage heart failure will be assessed using the Stanford Chronic Disease Self-Management measure (84). Couples are asked to rate their level of confidence to manage heart failure around six aspects of the illness (e.g., fatigue, emotional distress) on a 0 (no confidence) to 10 (a great deal of confidence) scale.

Socio-demographic and clinical characteristics

Surveys will also ask couples for key background and socio-demographic data, including, age, gender, length of relationship, educational status, employment status, race/ethnicity, time since diagnosis, stage of heart failure, HFpEF vs. HFrEF status, current heart failure medications, other chronic illnesses, and impact of the coronavirus.

Acceptability and Feasibility

There will be several indicators of feasibility and acceptability including refusal rate, number of sessions attended, and amount of time spent in each session. We will also assess satisfaction with the program (amount of relevant information provided, interpersonal qualities of the interventionist) and advantages and drawbacks (e.g., “I learned a lot during these sessions,” “The program took more time than I wanted to spend”). These measures were drawn from prior studies by members of this team (CJW) (86, 87). Additionally, in a series of closed and open-ended questions TCU participants will be asked about length of sessions, time between sessions, # of sessions and preferred delivery modality and two open-ended questions regarding benefits and drawbacks of the program.

Analytic Plan

Standard descriptive statistics of frequency, central tendency, and dispersion will be used to describe the sample. All analyses will be performed using SPSS v27 (Chicago, IL) and HLM v8 (Skokie, IL). Our aims will be analyzed using multilevel modeling (MLM) to control for interdependencies of the dyadic data and autocorrelations among repeated assessments. In order to estimate the preliminary efficacy of the TCU program on dyadic health (i.e., better global health, lower depressive symptoms and anxiety, and less healthcare utilization) and dyadic management (i.e. greater collaborative management and coping, more open communication and greater confidence), we will run a series of longitudinal APIM (matched pairs) models to simultaneously examine adult with heart failure and partner trajectories in health and dyadic management variables over time (controlling for interdependent data). Each within-couple model has four coefficients representing intercepts (baseline assessments) and slopes (rates of change) for adults with heart failure and their partners that become outcome variables in an unconditional between-couple model. Conditional between-couple models will examine the effect of GROUP on adult with heart failure and partner health and dyadic management variables. A significant coefficient for GROUP on the slope parameter and a significantly better fitting model (as evidenced by the deviance statistic) will indicate the rate of change across time is statistically dependent on treatment condition. For individual level health variables (i.e., care strain and heart failure specific-QOL) individual MLM will be used to examine the role of GROUP.

In order to estimate preliminary efficacy of the intervention on dyadic appraisal (regarding dyspnea, pain and fatigue) a longitudinal incongruence model will be used to directly examine couple dyadic appraisal over time (88), where the slope represents the pattern of change in incongruence (gap in appraisal between the two members of the couple). Three separate models will be estimated for each outcome (dyspnea, pain, and fatigue). We will know how large the gap is, the type of gap (e.g., partner rating lower than adult with heart failure) and how the gap changes over time (e.g., increases, decreases, remains stable). The effect of the TCU program on dyadic appraisal will be tested directly by examining the role of GROUP. Given the preliminary nature of the study, we will conduct two-sided statistical tests with p < .05 without correction for multiple tests.

We will examine the feasibility and acceptability of the TCU intervention in several ways. First, adherence to the program will be examined in proportion of couples who completed 5 of the 7 TCU sessions. Feasibility will be assessed by examining refusal rate, number of eligible couples who enrolled in the study, and number of enrolled couples who complete the T2 and T3 surveys. Concurrent quantitative measures assessing satisfaction and advantages and drawbacks of the TCU program and two open-ended questions will be used to determine the acceptability of the program and any needed changes. Qualitative responses will be descriptively examined for value-added information to refine the program and understand quantitative responses. Our use of quantitative and qualitative data to evaluate feasibility and acceptability will help glean more broadly the strengths and limitations of the program and greatly inform any revisions to session content/delivery, as well as unforeseen benefits/risks of the program before moving to future trials.

Sample Size Justification

With 72 couples (144 participants total), and allowing for a 17% missing data rate (i.e., 60 dyads), we have 80% power to detect a 6.6 point difference in dyadic PROMIS global health scores between intervention and control groups (score mean = 50, SD = 10), which is greater than a minimally clinically important difference (estimate of ½ SD (5) due to no additional estimates available). These preliminary data are required to determine the sample size needed for a larger trial.

This program is the first known heart failure dyadic intervention that will target specific, modifiable aspects of the dyadic relationship (i.e. collaboration, communication and confidence) to foster skills to enhance the way couples appraise and manage heart failure together. The program is tailored to the strengths and challenges for each couple and facilitates the creation of shared goals for each couple and the strategies to obtain them as a team. Our program is dyad-based (i.e. includes both members of the couple) and dyad-focused (i.e., targets the outcomes of both members and facilitates a collaborative approach to management needs of each member) (31). We will evaluate the preliminary effects of the program using a combination of dyadic methodologies that allow us to begin to identify the ways in which TCU benefits the couple versus the individual, and for which couples the benefit is greatest.

This trial is the natural next step to advance understanding of heart failure management within the context of a couple and begin to address the lack of interventions that optimize the outcomes of both the adult with heart failure and their partner (10). The findings of this study will not only inform refinement of the TCU program, but also lead to larger, more comprehensive trials.

TCU

Taking Care of Us

Ethics approval and consent to participate

Written informed consent is obtained for all participants. The study was approved by the institutional review board at Boston College (IRB# 21.074).

Consent for publication

Not applicable

Availability of data and materials

The datasets generated and/or analyzed during the current study are not publicly available due to confidentiality but may be available from the corresponding author on reasonable request.

Competing interests

The authors have no competing interests.

Funding

The study was funded by the National Institute on Aging of the National Institutes of Health under Award Number R21AG068715 (KSL & CSL). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Authors’ contributions

KSL and CSL conceptualized and designed the study and two intervention programs, obtained funding, drafted and critically revised the manuscript. CJW contributed to the design of the study and TCU program and critically revised the manuscript; SHJ contributed to the design of the study and critically revised the manuscript; ARV, JNU and JM recruit participants and critically revised the manuscript. All authors have approved the submitted version.

Acknowledgements

The authors would like to acknowledge research staff members Emma Zingg, Leah Sherman-Collins, Vanessa Chatfield, Vidisha Pandey, Christine Flatley and Caroline Tennant and safety monitoring committee members Susan Pressler and Lee Ellington for their roles on the study.

Authors’ information (optional)

KSL: Professor, Boston College William F. Connell School of Nursing, Chestnut Hill, MA, USA

CJW: Assistant Director, Center for Research and Education, Benjamin Rose Institute on Aging, Cleveland, OH, USA

ARV: Medical Director, Cardiac Transplantation Program, Tufts Medical Center, Boston, MA, USA; Associate Professor, Tufts University School of Medicine, Boston, MA, USA.

JNU: Medical Director, Cardio-Oncology Program| Division of Cardiology, Tufts Medical Center, Boston, MA, USA; Assistant Professor, Tufts University School of Medicine, Boston, MA, USA

SHJ: Co-founder, Canopy Consultants Inc., Arlington, MA, USA

JM: Postdoctoral Research Fellow and Project Coordinator, Boston College William F. Connell School of Nursing, Chestnut Hill, MA, USA

CSL: Professor and Associate Dean for Research, Boston College William F. Connell School of Nursing, Chestnut Hill, MA, USA; Professorial Fellow, Australian Catholic University Mary MacKillop Institute for Health Research, Melbourne, Australia

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Taking Care of Us (TCU) Study Protocol: A Dyadic Intervention for Couples Living with Heart Failure

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Background

Methods

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Participants

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Intervention Group

Control Group

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Safety

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Measures

Health

Dyadic Appraisal

Dyadic Management

Confidence

Socio-demographic and clinical characteristics

Acceptability and Feasibility

Analytic Plan

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