DOI: https://doi.org/10.21203/rs.3.rs-1900164/v1
A double-blinded randomized controlled trial.
The present research aimed to investigate the effects of a self-efficacy-centred self-management program on persons with neurogenic bladder (NGB) after spinal cord injury (SCI).
The spinal surgery department of the Third Affiliated Hospital of Soochow University, Changzhou, China.
Eighty-two individuals with NGB after SCI were randomized into the control or intervention group. The control group received standard admission and discharge education and follow-up. The intervention group received the self-efficacy-centred self-management programme. Self-efficacy was assessed at preintervention, 4 weeks, 8 weeks and 12 weeks postintervention. Self-management ability, the incidence of UTI, residual urine volume, bladder safety capacity and quality of life were assessed at 12 weeks postintervention. The data obtained were analysed using SPSS 26.0.
Ultimately, 79 participants (control group: n = 39, 66.67% males, intervention group: n = 40, 57.50% males) received the full intervention. A significant difference was observed in self-efficacy between the control and intervention groups (2.54 ± SD 0.247 versus 2.71 ± SD 0.218, mean 95% CI: 0.174, 0.070 to 0.278, p < 0.05) at 12 weeks postintervention. Significant differences (p < 0.05) were observed in self-management ability, the incidence of UTI, residual urine volume and bladder safety capacity between the groups at 12 weeks postintervention. There were significant differences in quality of life (vitality, mental health, p < 0.05) between the two groups.
The self-efficacy-centred self-management program developed in this study can significantly increase participants’ self-efficacy and bladder self-management ability, thereby improving their bladder functional status and quality of life.
Neurogenic bladder (NGB) secondary to spinal cord injury (SCI) can lead to many complications that have a significant impact on the health and quality of life (QOL) of persons [1, 2]. NGB often manifests as aberrant filling and emptying of the bladder, mainly involving inability to empty the bladder voluntarily, hyperactivity, changes in capacity, and impaired bladder wall compliance due to fibrosis [3]. These changes may cause a series of urinary tract complications, such as urinary tract infections (UTIs), urinary stones, hydronephrosis, urosepsis, renal failure and related cancers [4, 5]. In fact, urinary tract symptoms and complications have become the most common cause of readmission in persons with SCI [6].
A retrospective cohort study showed that 74.3% of persons with SCI were diagnosed with bladder dysfunction during acute care; three months later, more than 90% of the individuals reported bladder dysfunction [7]. Among the top ten research priorities for SCI, bladder management is at the forefront [8]. Therefore, the bladder self-management ability of persons with SCI should be promoted to prevent urinary tract complications and improve excretion-related QOL [9].
Some scholars believe that SCI should be considered a chronic disease, not accidental injury, due to the high risk of SCI-related secondary health conditions (SHCs) and the nature of chronic diseases [10]. Consequently, we should pay more attention to the critical role and responsibility of persons with SCI in maintaining their health and participating in society [10]. In chronic disease management, individual self-efficacy is a necessary condition for self-management [11]. Self-efficacy refers to an individual’s belief or self-confidence in his or her own ability to successfully complete a specific task or behaviour in the future [12]. Previous qualitative studies have found that self-efficacy is an important facilitator of self-management in persons with SCI [13, 14]. The development of self-efficacy support interventions will not only improve the self-management of persons with SCI, but also compensate for the lack of long-term health care services [15].
The positive impact of self-efficacy on persons with SCI has been widely studied, but few intervention studies have focused on self-efficacy. This article presents the results of a randomized controlled trial (RCT) evaluating the effect of a self-efficacy-centred self-management program in persons with neurogenic bladder due to SCI. We hypothesized that enhanced self-efficacy could promote bladder self-management abilities in individuals, thereby improving bladder functional status and QOL, and preventing urinary tract complications.
The RCT study was conducted in China between February 2021 and March 2022 according to the amended Declaration of Helsinki. Participants who met the inclusion criteria were first contacted by visiting them in their room. Written and verbal consent was obtained from each participant (including their primary caregivers) after a full explanation of the research procedures. All participants could withdraw from this research at any time without adverse consequences. The research and procedures were approved by the ethical committee of the Third Affiliated Hospital of Soochow University (2021-CL002-01). The study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org, ChiCTR2200056523). The CONSORT guidelines were followed during the course of the study.
Participants were randomly assigned in equal proportions to the intervention (with an odd number) or control (with an even number) groups. The randomization sequence was generated by a statistician who does not know the content of this study through a computer-based randomizer (https://www.randomizer.org). Then, the printed sequence was loaded into an opaque envelope and passed to the recruitment team.
The participants (N = 82) were recruited from the spinal surgery department of a large general hospital in Changzhou. To be included in this research, participants must meet the following inclusion criteria: (1) aged between 18 and 65 years old; (2) SCI confirmed by magnetic resonance imaging (MRI), meeting the diagnostic criteria for NGB [16] and first admission; (3) American Spinal Injury Association (ASIA) Impairment Scale scores B, C, D; (4) injury level located in C5 ~ S5; (5) upper extremity (UE) motor scores [17] no less than grade 3; and (6) participants and their main caregivers have network equipment and are able to use it. Exclusion criteria included: (1) individuals with severe physical diseases; (2) abnormal urethral anatomy, urinary tract injury and serious urinary tract infection; (3) grievous urinary incontinence, bladder safety capacity less than 100 mL; and (4) cognitive, psychological and mental disorders.
The demographic and disease-related questionnaire was designed based on a literature review to collect baseline data on participants at admission. Demographic information included age, sex, height, weight, educational experience, and marital status. Disease-related information included aetiologies of injury, levels of injury, and ASIA Impairment Scale score. All outcomes were measured by the same evaluator, who was blinded to participant group assignment. Except for patient self-efficacy (preintervention, 4 weeks postintervention, 8 weeks postintervention, 12 weeks postintervention), all other outcomes were measured at 12 weeks postintervention.
The primary outcomes were self-efficacy measured by the General Self-Efficacy Scale (GSES), self-management ability measured by the Self-Management Scale for Neurogenic Bladder Patients, and QOL measured by the MOS 36-Item Short Health Survey (SF-36).
The GSES includes 10 items rated on a 4-point Likert scale (1 = not at all true to 4 = exactly true), with total scores ranging from 1.0–4.0. The higher the score is, the higher the individual’s perceived self-efficacy. In our study, we selected the Chinese version (constructed by Zhang and Schwarzer) of the GSES (α = 0.91) [18]. Peter et al. used the Rasch analysis method to verify that the GSES is a reliable psychological measurement tool for persons with SCI [19].
The Self-Management Scale for Neurogenic Bladder Patients was developed by Chinese scholars Liu Yu et al. [20]. The 29-item scale consists of 3 dimensions, including knowledge (9 items), attitude (10 items) and behaviour (10 items). Each item of the knowledge dimension is scored on a 2-point scale (0 = no, 1 = yes). Each item of the attitude dimension is scored on a 5-point Likert scale (0.2 = strongly disagree to 1.0 = strongly agree). Each item of the behaviour dimension is scored on a 5-point Likert scale (0.2 = never to 1.0 = always). Reverse semantic items are reverse scored. The Cronbach's α coefficient and content validity index of the total scale were 0.725 and 0.900, respectively. A higher score reflects a higher self-management ability of neurogenic bladder persons.
The SF-36 [21] assesses 8 dimensions: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The score for each subscale is the weighted sum of the items for that subscale, transformed into a 0-100 scale, where higher scores indicate better health and QOL [22]. Studies have shown that the SF-36 has is the most common tool for evaluating the objective QOL among persons with NGB after SCI [23].
Secondary outcomes included the incidence of UTI, residual urine volume and bladder safety capacity.
The diagnostic criteria for UTI and bacteriuria were based on previous studies [24]. Incidence was defined as the number of UTI or bacteriuria cases in the population during the course of the study divided by the total number of people at risk of infection.
Residual urine volume was defined as the volume of urine remaining in the bladder after spontaneous voiding in persons with SCI. Residual urine volume was measured by urinary catheterization or B-mode ultrasonography.
Bladder safety capacity is defined as the maximum capacity within the bladder when the safety pressure does not exceed (≤ 40 cm H2O). Bladder safety capacity was measured by the modified bladder capacity measurement method.
The duration of the intervention for each group of participants was 12 weeks from the time each subject agreed to participate in the study. The participants completed various examinations within one week after admission and then underwent surgery (decompression, internal fixation and fusion). The length of hospital (LOS) stay for each participant was generally controlled at approximately 1 month. All measures were performed by the same intervenor (different from the control group), who was blinded to participant group assignment.
The control group received routine standard admission and discharge education. After admission, the participants issued the guidance manual for bladder function training in persons with SCI (http://www.spinalcordessentials.ca), followed by routine education and guidance such as intermittent catheterization, drinking plan, voiding diary, common urinary system complications, bladder retraining, daily management knowledge of bladder dysfunction (including the treatment of urinary incontinence symptoms) and follow-up recommendations. The participants were followed up by telephone every 2 weeks after discharge and home visits were conducted at weeks 8 and 12 (rehabilitation assessment and continuous care support).
The intervention group received a self-efficacy-centred self-management program. The program was constructed based on two rounds of evidence-based and one round of expert meeting consultation. Based on the practical evidence of self-efficacy enhancement measures in patients with SCI (second round of evidence-based results) as a framework, combined with the practical evidence of rehabilitation management in persons with neurogenic bladder (first round of evidence-based results), the self-efficacy-centred self-management program of this study was preliminarily constructed. Finally, through expert meeting consultation, the preliminary intervention program of this study was improved. The self-efficacy-centred self-management program of this study included three phases.
Phase 1: Admission to preoperation
“One-to-one” bedside interview with participants and their primary caregivers. First, the treatment, nursing needs and psychological status of the participants were understood. Second, the knowledge of SCI related diseases and treatment, bladder training skills, prevention and nursing measures of secondary complications after other common SCI, and self-efficacy theory were introduced.
Participants and their primary caregivers watched videos showing better rehabilitation effects of persons with SCI to inspire participants’ confidence in rehabilitation treatment.
Participants and their primary caregivers received the content of voiding diaries and drinking plans, laying the foundation for the participant’s bladder training management in the next phase.
Help participants establish small goals for staged rehabilitation (goal setting); jointly establish rehabilitation action plans with participants (behaviour engagement); evaluate, feedback and supervise participants’ action plans (evaluation feedback).
Participants were encouraged to join the communication WeChat group of neurogenic bladder participants (wherein relevant rehabilitation nursing information was regularly communicated).
Phase 2: Postoperation to discharge
“One-to-one” bedside education course (multimedia) with participants and their primary caregivers. The course content includes the importance of rehabilitation nursing for persons with SCI, how to carry out rehabilitation training and nursing of bladder dysfunction, prevention and nursing of common complications of bladder training, and how to establish a reasonable rehabilitation attitude after SCI.
Daily guidance and supervision on the implementation of the participant’s voiding diary and drinking plan.
Guide participants and their primary caregivers to conduct clean intermittent catheterization training on urethral models (if necessary).
Instruct and supervise the participant’s daily behaviour training (timed voiding, delayed voiding, conscious voiding, etc.).
Three groups of participants, researchers and nursing staff (peer mentorship) were formed to form peer support. Nursing staff provided full rehabilitation guidance and support to participants. Researchers carried out quality control and evaluation, and timely feedback during this process.
Participants meeting before discharge. The meeting focused on how to manage negative emotions, how to accept life with symptoms, and special guidance for discharge.
Phase 3: Postdischarge guidance
Participants were followed up by telephone every 2 weeks after discharge and home visits were conducted at weeks 8 and 12.
Internet meeting. In weeks 7 and 11, participants were invited to watch a bladder self-management video through a conference software (Tencent Meeting).
Participants were encouraged to submit, on a biweekly basis, photo-based voiding diary and water drinking records and to respond promptly.
The sample size was calculated using PASS 15 (NCSS, LLC., Kaysville, Utah, USA) and was guided by the estimates of minimal clinically important differences in self-efficacy in patients with SCI. The required minimal clinically important difference (2.9) and standard deviation (4.25) were determined by comprehensive analysis of data reported from relevant studies [25]. For the Tests for Two Means in a Repeated Measures Design procedure, with a power of 0.80, a significance level of 95%, a Rho of 0.65, and 4 Repeated Measurements, 25 subjects per group are needed. Given an expected a dropout rate of approximately 10% over the course of the trial, 3 additional subjects were assed to each group. Therefore, the total number of subjects required was 56. A total of 82 subjects participated in this research.
The data obtained were analysed using Statistical Package for Social Science 26.0 (IBM SPSS Inc., Armonk, NY, USA). Descriptive statistics, including frequencies, means, and standard deviations, were calculated for participant baseline characteristics. The Shapiro-Wilk test was performed to test the normality of continuous data. Normally distributed baseline data (age, BMI) were compared using an independent samples t-test. Nonnormally distributed data were compared using the chi-square test. For each outcome variable measured, between-group differences were assessed using the independent samples t-test or the Mann-Whitney U-test for continuous data and the chi-square test for categorical data. To highlight any significant changes in participants’ self-efficacy, repeated measures analysis of variance (ANOVA) and further comparative analysis were performed in each group. The statistical significance level was set at 0.05.
Among 125 participants with SCI caused by trauma, 82 participants were ultimately randomly divided into two groups for different intervention measures. The detailed distribution of the participants is shown in Fig. 1.
Participant characteristics
The baseline characteristics of the participants are shown in Table 1. The mean age was 51.05 years (SD = 9.69) in the control group (n = 39, 66.67% males) and 51.58 years (SD = 12.82) in the intervention group (n = 40, 57.50% males). No differences (p > 0.05) were found between groups at baseline (Table 1).
Self-efficacy
The values of self-efficacy and corresponding statistical analysis results are shown in Table 2. The self-efficacy levels of participants in the groups showed an upwards trend in the overall intervention process (Fig. 2). A significant difference (p < 0.05) was observed in self-efficacy between the groups at 12 weeks post intervention. There was no significant difference in the level of self-efficacy among the groups (F between-group = 2.014, partial η2 = 0.025, p > 0.05), which revealed that the effects of different interventions in the two groups on the self-efficacy scores of the participants were not significant. There were statistically significant differences in the levels of self-efficacy between the groups at the four assessment time points (F time = 126.174, partial η2 = 0.621, p < 0.05), which revealed that the efficacy scores of the two groups showed an increasing tendency over time. The time*between-group interaction effects of self-efficacy level in each group were statistically significant (F interaction = 11.420, partial η2 = 0.129, p < 0.05), which revealed that the change in self-efficacy score in the control group at different time periods was significantly different from that in the intervention group at the time period.
Self-management ability and quality of life
Significant differences between the groups were observed in self-management ability (knowledge, attitude, behaviour, p < 0.001) and SF-36 scores (vitality, mental health, p < 0.05) after intervention (Table 3).
Secondary outcomes
Significant differences between the groups were observed in the incidence of UTI, residual urine volume and bladder safety capacity (p < 0.05) after intervention (Table 4).
NGB care and treatment after SCI are very challenging. Considerable progress has been made in urological management (anticholinergics, botulinum toxin and surgical treatments, etc.) of persons with SCI over the past few decades, but due to social, economic and resource constraints, noninvasive medical management is the key to improving disease symptoms and QOL in this population [26]. The primary content of conservative management of persons with NGB is to carry out patient education to promote suboptimal self-management [4]. Previous studies have demonstrated the importance of mentoring and educating persons with SCI during the acute phase to improve rehabilitation outcomes [27, 28]. In addition, we should focus on the direct responsibility of persons with SCI themselves for self-management behaviours in their daily lives [29]. Given the positive role of self-efficacy in the rehabilitation process of persons with SCI, taking essential interventions to enhance their self-efficacy seems to be an excellent way to achieve the above goals.
The implementation of the self-efficacy-centred self-management program constructed based on evidence-based concepts can effectively enhance the self-efficacy level of participants. A significant difference in self-efficacy was found between the groups at 12 weeks postintervention, which provided a reference for the establishment of the duration of subsequent intervention studies. Moreover, this intervention significantly promoted bladder self-management ability (knowledge, attitude and behaviour) among participants. The self-efficacy level and self-management ability of the participants after the intervention were consistent, and the participants with high self-efficacy also had a higher self-management level. Furthermore, this intervention significantly reduced the incidence of UTI, decreased residual urine volume and increased bladder safety capacity, suggesting that the participants’ bladder functional status had improved. Improvements in bladder functional status depend on the combined efforts of health care professionals, participants and their primary caregivers. Finally, the QOL of the intervention group was better than that of the control group after intervention, especially in the VT and MH dimensions. This implies that the improvement of the QOL of the participants is mainly reflected in the psychosocial aspect.
According to the original hypothesis of this study, the improvement of the participants’ bladder functional status depends on the enhancement of their bladder self-management ability, and the enhancement of bladder self-management ability depends on the improvement of their self-efficacy, which is ultimately reflected in the optimization of QOL. Based on Bandura’s proposed pathway (performance accomplishments, vicarious experience, verbal persuasion, physiological/emotion arousal) for changing individual self-efficacy [12], this original hypothesis appears to be flawed. There was no simple cause-and-effect relationship between participants’ improved self-efficacy and meliorative self-management ability. We believe that the enhancement of participants’ self-management ability depends on a variety of support given by health care professionals; the enhancement of self-management ability inherently stimulates the improvement of participants’ self-efficacy, which in turn promotes the self-management ability of participants. In other words, the improvement of participants’ self-efficacy and self-management ability is mutually reinforcing in this study, which is a benign cycle. In addition, the improvement of participants’ self-efficacy also helps to prevent SHCs after SCI, combat negative psychosocial problems and promote the overall QOL.
NGB is very common after traumatic SCI. Therefore, early intervention is essential to prevent urological complications, improve prognosis and plan rehabilitation [7]. Management of NGB is often lifelong, and in addition to patient education, enhanced training for community health professionals is also important [28]. Rehabilitation care patterns for NGB after SCI are still evolving, but attention should be devoted psychosocial topics related to individual bladder management [30].
The limitation of this research must be mentioned. First, the recruited participants were from only one large comprehensive hospital. Further multicentre research is suggested to increase the representativeness of the recruited samples. Second, the intervention duration of this study was only 12 weeks, so the long-term effect of the intervention could not be observed. RCTs with longer study durations are suggested to explore the trajectory of participants’ self-efficacy. Finally, since no QOL assessment tools for NGB after SCI have been developed in China, this study adopted a nonspecific assessment tool. Specific assessment tools (i.e., Quality of Life Index, Qualiveen etc.) are recommended in future studies to evaluate the impact of NGB on the QOL of persons with SCI.
The self-efficacy-centred self-management program constructed in this study can significantly increase participants’ self-efficacy and bladder self-management ability, thereby improving their bladder functional status and QOL. Further research is needed to validate the preliminary results on the effect of challenging NGB for persons with SCI. In the rehabilitation management of NGB persons after SCI, it is extremely important to pay attention to self-efficacy. The most important part of improving individual self-efficacy is how to obtain “environmental” support, which will help improve the overall QOL of persons with NGB after SCI.
The datasets generated and/or analyzed during the current research are available from the corresponding author on reasonable request.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
ACKNOWLEDGEMENTS
The authors would like to acknowledge all participants and the research support from the Third Affiliated Hospital of Soochow University.
FUNDING
This research was supported by the Young Talent Development Plan of Changzhou Health Commission (2020-233, CZQM2020057).
AUTHOR CONTRIBUTIONS
TXX, HJ, LQ and YZP were responsible for designing the research, conducting the research, analyzing the data, writing the article, and submitting the article. TXX and HJ were responsible for analyzing the data. TXX, LQ, WWY and SXP were responsible for collecting the data.
ETHICAL APPROVAL
The research and procedures were approved by the ethical committee of the Third Affiliated Hospital of Soochow University (2021-CL002-01). The research was registered in Chinese Clinical Trial Registry (ChiCTR2200056523).
Tables 1-4 are available in the Supplementary Files section.