Setting and population
The study setting is the Joint Surgery Unit of the Orthopedics Department at a hospital.
Patients on the surgical waiting list for THA will be invited to participate in the study after preoperative assessment. Men and women aged 18 years or older and scheduled for primary, single-side THA surgery at the Joint Surgery Unit are eligible for participation. Trial inclusion criteria are as follows: participants must be able to read and understand Chinese, willing to participate in a 6-month exercise intervention, and provide informed consent. Participants are ineligible if they meet one or more of the following exclusion criteria: (i) an unstable medical condition due to fracture, malignancy, infection, or failure of THA; (ii) inability to provide informed consent due to mental disorder, dementia, or cognitive impairment that prevent completion of self-report surveys; (iii) co-existing conditions that would negate functional improvement with surgery and exercise (e.g., severe Parkinson disease, or hemiparesis); (iv) simultaneous bilateral THA; (v) surgery for neoplastic disease or imminently scheduled surgery and unavailable to complete the study procedures; or (vi) planning another THA or total knee replacement within 6 months.
Development of the SEEI program
Preparation phase
After reviewing international guidelines on the development of exercise interventions for adults undergoing hip surgery, the preparation of the SEEI program followed a three-stage process:
-
Setting up a nurse-led intervention team, mainly composed of orthopedic nursing clinical specialists, orthopedic surgeons, orthopedic physicians, senior orthopedic nurses, and research assistants, to control the overall research direction, formulate and evaluate intervention programs, and control the quality of research. A draft intervention was produced after a series of interviews with patients undergoing THA by experienced healthcare professionals; the specific content and protocol were subsequently validated by a panel of orthopedic experts.
-
Formulating the “Handbook for Rehabilitation after discharge following THA” including two main aspects: post-discharge guidance, including general information about home reorganization, functional exercise, matters or follow-up needing attention, and daily life guidance during each rehabilitation period after THA; and a functional exercise diary in the rehabilitation manual that is convenient for patients to record their exercises and any problems. The functional exercise and daily life guidance sections contain illustrations and detailed written explanations. Contact information for the department, orthopedic specialist, and orthopedic nurse is at the back of the guide. The handbook will be available for patients in both groups.
-
Registering a WeChat account for research and filming a functional exercise video. A WeChat account has been created specifically for the experimental group and is managed by a research assistant, as a convenient means to establish multiple contacts with patients and reduce follow-up loss. WeChat is used to promote exercise videos provided for patients and their families to learn about the various stages of joint replacement rehabilitation. WeChat will also be used to collect video data, including of exercise and walking, during the rehabilitation process.
Intervention theoretical framework
The intervention is based on Bandura’s self-efficacy theory [32], combined with social cognitive theory (SCT) [33]. Consistent with SCT, interventions target self-management knowledge, attitudes (self-efficacy), and behavioral abilities through a variety of printed materials and activities. The intervention program is also conducted according to Bandura’s self-efficacy theory [34], which includes four main aspects: individual past experience, witnessing the experiences of other individuals, verbal motivation from others, and physical and emotional support for patients, specific to the particular behavior [35]. The four strategies recommended by Bandura [36] have been incorporated into each component of the intervention. Individual past experience includes emphasizing the importance of functional exercise on the basis of the existing THA functional exercise table, helping participants to set achievable goals and actions, and encouraging participants to observe and record their exercise behavior and constantly accumulate self-management experience, according to their subjective physical experience. Vicarious experience includes sharing successful examples of patients who have experienced similar symptoms and recovered using self-management skills, to help participants build confidence, and encourage them to adhere to the functional exercise program. Verbal persuasion includes describing the benefits of exercise adherence to joint function, encouraging and acknowledging the participant’s ability to deal with symptoms, and helping those who encounter difficulties to find the causes and propose corresponding solutions. Psychological monitoring includes the explanation of possible symptoms during postoperative rehabilitation and the discussion of treatment strategies. Patients are supported in these four strategies during training sessions. Table 1 outlines examples of the four strategies [18].
Table 1
SEEI components, strategies, and techniques
Components
|
Strategies
|
Specific techniques
|
Individual past experience
|
• Setting achievable goals
• Providing information on the benefits of functional exercise
• Providing positive feedback
|
• Consulting with patients to develop functional exercise goals at different stages; making plans on when, where, and how to conduct regular physical activities
• Providing information on the risk factors of a sedentary lifestyle and the advantages of functional exercise
• Identifying postoperative rehabilitation challenges through discussion
• Providing positive feedback on patient accomplishments
|
Vicarious experience
|
Sharing cases of successful rehabilitation
|
• Sharing previous success stories to build confidence
• Introducing the successful experiences of others to encourage patients to complete physical activities in the following months
|
Verbal persuasion
|
Verbal encouragement, explanation, and persuasion
|
• Describing the benefits of physical activities
• Asserting that patients have the ability to self-manage
• Providing positive feedback on the patient’s efforts and giving verbal encouragement
• Reinforcing the past and present successes or accomplishments of patients
|
Supporting patients physically and emotionally
|
• Developing strategies to cope with barriers
• Help to seek social support
|
• Assessing patient expression of anxiety and depression
• Identifying individual barriers to and resources for physical activity
• Providing strategies for dealing with barriers and coping in the future (postsurgery; significance of social support)
|
Intervention structure and content
Challenges to successful post-THA functional achievement were identified, and strategies to address them were developed and integrated to design the intervention. Telephone interview was selected as the primary basis for the intervention because it is a low-cost, wide-coverage mechanism that can provide support intervention after THA for patients with limited mobility and transport difficulties [37]. Although this format has not been thoroughly investigated in patients with THA, it has been well-studied for patients with other conditions and used alone or in combination with face-to-face educational sessions and print materials [38, 39]. The initial intervention was further refined following a pilot pretest involving five patients.
The final intervention protocol includes a total of five sessions: one hour of face-to-face education before discharge, and four additional sessions post-discharge between 1 and 6 months after surgery. Except for the hospital visit, all visits are telephone based. The first call is approximately 40 min, with follow-up contacts ranging from 20 to 30 min. The intervention aims to enhance exercise adherence through the implementation of self-efficacy-enhancing strategies.
The initial face-to-face intervention is conducted in the hospital office before patients are discharged from the hospital after THA surgery. The focus of the initial session is to assess the functional exercise status and psychological condition of each individual, including the level of pain, the occurrence of complications, and knowledge of functional exercise. The nurse provides participants with the Rehabilitation Handbook after THA and instructs them to read it. The manual is used to supplement the face-to-face educational session. Participants are encouraged to refer to the manual at home for information. The nurses also provide video recordings of functional exercise after THA and teach patients the functional exercise movements and matters needing attention in daily life after surgery, as well as persuading and encouraging participants to set rehabilitation goals to be achieved one month post-THA, and mobilizing the encouragement and support of the participant’s family members.
During the 6-month follow-up period, four subsequent health-coaching sessions are conducted via telephone or the WeChat app. These sessions are designed to enhance participant compliance with functional exercises and are guided by a protocol. Participants in each follow-up are required to self-report the number of home exercises they have completed in the previous week, their level of pain, and their mental state. Nurses encourage and provide reinforcement of the participant’s efforts and success, and empower them through support. Participants with a low adherence (< 3 exercise sessions/week) are then asked to select a barrier from a scheduled list (forgot, too tired, injured so unable to exercise, fear of movement, exercise inconvenience, lack of time, life stress) to explain why they were unable to complete the exercise as required. The nurse then provides a suggestion tailored to help overcome that barrier. According to the needs of each patient, the duration of each phone call ranges from 20 to 30 min.
Four senior orthopedic nurses with bachelor degrees or above and at least 10 years of orthopedic nursing experience have been selected in the target hospital. All nurses have a specialist diploma, are very familiar with the physical and psychological problems and rehabilitation needs of patients after THA, and establish close relationships with the patients. Simultaneously, two research assistants are assigned to conduct the interventions with the patients, primarily through collection of questionnaire data, and assist with relevant intervention content. The two research assistants are very familiar with the care of patients undergoing joint replacement. Two days of training are provided for the nurses before intervention implementation, primarily including: communication skills, consistency of the intervention program, strategies to encourage physiological and psychological changes, detailed descriptions of problems that occur in the rehabilitation process after THA, dos and don’ts for the telephone follow-up, and matters included in the intervention follow-up record form. All staff also receive training on the study protocol and the procedures for collecting informed consent and data assessment. The principal investigator will monitor the conduct of the intervention through observation sampling sessions.
Assessment of outcomes
All assessment sessions (baseline [time 1], 1 month [time 2], 3 months [time 3], and 6 months [time 4] post-surgery) include measurement of the primary and secondary outcomes. A series of questionnaires related to health outcomes of the SEEI is implemented. During the baseline assessment, additional demographic information including health, medical history, and general health status is collected.
Primary outcomes
Self-efficacy for rehabilitation (SER) outcome scale
The 12-item SER was developed by Waldrop et al. [40], following Bandura’s guidelines [33] to assess participant beliefs about their ability to perform behaviors typical in physical rehabilitation for knee and hip surgery. The SER was developed in conjunction with rehabilitation psychologists and physical and occupational therapists. Items increase in difficulty (e.g., items assessing self-belief in ability to stretch a leg, to those assessing beliefs in one’s ability to walk). Items measure belief in ability to perform behaviors in varying therapy situations, including when experiencing pain and emotional distress. For each item, participants use an 11-point Likert scale, ranging from 0 (I cannot do) to 10 (certain I can do) to describe their confidence. The full score for the items is 120, and higher scores indicate more perceived self-efficacy for rehabilitation. According to Bandura [33], “efficacy scores are summed and then divided by the total number of items to indicate the strength of perceived self-efficacy for the activity domain.” Thus, mean self-efficacy scores were calculated. In this study, the reliability and validity of the Chinese version SER outcome scale will be assessed by six orthopedic nurses. The Cronbach’s alpha reliability coefficient value for the total scale was 0.942.
Functional exercise compliance scale for THA patients
The self-designed exercise compliance questionnaire was developed by Xinxin Li of Sun Yat sen University [29]. It can be divided into three dimensions: physical exercise compliance, exercise monitoring compliance, and initiative-seeking advice compliance. Each item is rated on a 4-point scale (4 points = “always do,” 3 points = “almost always do,” 2 points = “occasionally do,” and 1 point = “never do”). The sum of item scores is the total score, with higher total scores indicating a greater level of compliance level with functional exercise. In this study, Cronbach’s alpha ranges from 0.915 to 0.947, with an intra-rater reliability value of 0.92.
Secondary outcome measures
Overall hip pain
Average overall hip pain in the past week is self-assessed using a 11-point numeric rating scale with score 0 representing “no pain” and 10 representing “extreme pain” (e.g., “pain as bad as you can imagine” or “worst pain imaginable”) [41–43]. Participants select the whole number (0–10) that best reflects the intensity of their pain.
Activity and participation (WHO-DAS II)
The World Health Organization Disability Assessment Schedule II (WHO-DAS II) was developed based on the concepts and theoretical models of the 2001 International Classification of Functioning, Disability and Health, regarding the general evaluation and measurement of health conditions, disabilities, and psychometric variables [44]. The WHO-DAS II provides a standardized cross-cultural method for measuring the health and disability status of adults (aged over 18 years) over a 30-day period and contains 32 items covering six domains: cognition, mobility, self-care, getting along with people, activities of daily life, and social participation [45]. Scores are classified into five levels: no difficulty, mild difficulty, moderate difficulty, severe difficulty, and extreme difficulty [46]. The total score range is 0–100, with higher scores indicating higher limitations in daily life. In this study, the reliability of Cronbach’s alpha and intraclass correlation coefficient in the WHO-DAS II are 0.73–0.99 and 0.8–089, respectively, illustrating that the Chinese version is suitable to assess activity and participation [47].
Anxiety and depression
Anxiety and depression are measured using the Chinese version of the Hospital Anxiety and Depression Scale (C-HADS) [48]. The HADS is a self-report questionnaire designed to assess depression and anxiety and has been widely used among patient groups [49]. This instrument consists of 14 items (7 for anxiety [HAD-A] and 7 for depression [HAD-D]), which are used as two separate measures of psychological disturbance. Each subscale is scored from 0 to 21, with higher scores indicating greater distress. The psychometric properties of C-HADS have been confirmed, with satisfactory results in terms of reliability and validity [48]. In this study, the Cronbach’s alpha reliability coefficients for both the anxiety and depression subscales are both 0.85 [50].
Hip function
Hip function is monitored using the Harris Hip Score (HHS) for hip arthroplasty, a multidimensional disease-specific observational assessment of functioning, containing eight items representing pain, walking function, activities of daily living, and range of motion of the hip joint [51]. The HHS is widely used by physicians to assess physical function and pain relief in patients with hip disease [52]. The maximum score for the HHS is 100 points, with maximum possible scores for its components as follows: pain (44 points), function (47 points), range of motion (5 points), and deformity (4 points) [53]. A higher HHS score indicates better function.
QOL
Physical and mental health are assessed using the 12-item Short Form Health Survey (SF-12), a validated measure of QOL following joint replacement [54]. The SF-12 comprises 12 items for assessing physical and mental health and yields two summary scores: the physical and mental health composite scores [55]. Scoring is norm-based, with a mean of 50 (SD = 10); lower SF-12 scores indicate poorer physical and/or mental health. The Chinese versions of SF-12 components are established as reliable and valid in older patients [56].