Effect and Cost Effectiveness of a Dyadic Empowerment-based Heart Failure Management Program for Self-care

Study Overview
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Brief Summary
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Global population aging has drastically increased healthcare spending worldwide, with the greatest portion going to hospital and community health services. Heart failure (HF), as the final form of many cardiovascular diseases resulting from insufficient myocardial pumping. Ineffective self-care is consistently identified as the major modifiable risk factor for HF decompensation requiring hospitalization. It refers to an active cognitive process that influence patients' engagement in self-care maintenance, symptom perception and self-care management. However, current studies pay much focus on interventions such as motivational interviewing and behavioural activation to enhance the HF-related self-care and health outcomes which only produces short-term benefits. In fact, the lack of a sustainable effect from the self-care supportive interventions might be related the use of patient-centric design in these studies, which totally ignores the fact that HF management takes place in a dyadic context. To advance, active strategies were adopted to mobilize collaborative effort of the dyad in actual disease management. This study aims to evaluate the effects and cost-effectiveness of a Dyadic empowerment-based Heart Failure Management Program (De-HF) for self-care, health outcomes, and health service utilization among HF patients who require family support after hospital discharge. The De-HF program is based on the Theory of Dyadic Illness Management to enhance the congruence in illness perception and active dyadic collaboration in managing HF via both face-to-face and online platforms.

Detailed Description
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This is a mixed-method RCT to evaluate the effects and cost-effectiveness of the Dyadic Empowerment Heart Failure Program on improving self-care, health-related quality of life, hospital readmission and emergency room utilization among the HF patients discharged from the hospital. The study will be conducted in two regional hospital in Hong Kong, with subjects to be recruited from the in-patient setting. They need to have an index diagnosis of HF in admission, at New York Heart Association Classification Class II-IV, to be discharged home and with Abbreviated Mental Test score >6. The caregiver need to the primary caregivers, co-residing with the patients, and have access to smartphone. Power analysis estimate the sample size as 226 care dyads who will be allocated in a 1:1 ratio to receive the DE-HF Program of the education intervention. The 16-week De-HF program will be commenced within 2 weeks of discharge. It will starts with a dyadic interview in a home visit to identify the usual pattern of collaboration, deficits, strengths and competing concerns in disease management. This is followed by five empowerment modules with the purpose to help the care dyads to get a consensus and optimize their joint efforts in disease management. The five topics include symptom management, dietary and fluid modification, medication management, symptom management, activity and exercise. For each module, there are two sessions for i) perception and cognitive empowerment and ii) develop collaborative goal attainment process. Upon the completion of the ten sessions, two bi-weekly telephone calls will be made to the care dyads to monitor their level of goal attainment, and to give further advice and counselling. The 16-week dyadic education program will cover one home visit to assess their disease management at home, and this will be followed by five standard bi-weekly online education session on the same topics as the modules in the De-HF program. Outcome evaluation will take place at baseline, post-test, 24th week and 32rd week with validated measure.

Official Title
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The Effects and Cost-effectiveness of a Dyadic Empowerment-based Heart Failure Management Program (De-HF) on Self-care, HRQL and Hospital Readmission: A Randomized Controlled Trial

Conditions
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Heart Failure, Self Care, Empowerment, Transitional Care, Disease Management

Intervention / Treatment
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* Other: Dyadic empowerment based heart failure management program
* Other: Dyadic education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 55 or over Confirmed medical diagnosis of Heart Failure by a cardiologist of at least 6 months New York Heart Association (NYHA) Class II-IV symptoms Discharged home after an admission to the recruitment setting Carer co-residing with the patients in the same household Carer self-identified as the primary carer for the patients Both the patient and the carer having adequate cognitive ability (as indicated by an Abbreviated Test Score of >6) Have at least one Smartphone or device to access the online meetings and videos Exclusion Criteria: Not living with primary caregiver With end-stage renal disease relying on hemodialysis rather than HF medications to regulate fluid volume.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dyadic Empowerment-based Heart Failure program (De-HF)<br>The 16-week De-HF Program is delivered on a dyadic basis. The program consists of three core elements: i) joint dyadic interview in a home visit (1st-2nd week), ii) five ICT-enhanced empowerment-based modules (3rd-12th week; 2 sessions/ each module), and iii) post-module telephone follow-up (13th-16th week). The overall aim of the dyadic interview is to understand their usual pattern of collaboration, deficits, strengths and competing concerns in disease management. This is followed by the empowerment modules with the purpose to help the care dyads to get a consensus in disease interpretation (1st session: Perceptual and Cognitive Empowerment Session) and develop collaborative goal attainment process (2nd Session: Collaborative Gaol-Setting Process). This will be followed by two bi-weekly telephone calls to the care dyads using a speaker phone to monitor their level of goal attainment for the five modules, and to give further advice and counselling. | Other: Dyadic empowerment based heart failure management program<br>* The 16-week De-HF Program is delivered on a dyadic basis, The program consists of three core elements: i) joint dyadic interview in a home visit (1st-2nd week), ii) five ICT-enhanced empowerment-based modules (3rd-12th week; 2 sessions/ each module), and iii) post-module telephone follow-up (13th-16th week). The overall aim of the dyadic interview is to understand their usual pattern of collaboration, deficits, strengths and competing concerns in disease management. This is followed by the empowerment modules with the purpose to help the care dyads to get a consensus in disease interpretation (1st session: Perceptual and Cognitive Empowerment Session) and develop collaborative goal attainment process (2nd Session: Collaborative Gaol-Setting Process). This will be followed by two bi-weekly telephone calls to the care dyads using a speaker phone to monitor their level of goal attainment for the five modules, and to give further advice and counselling.<br>|
| Active Comparator: Dyadic education program<br>The 16-week HF education program comprises a home visit, five bi-weekly online training sessions, and the subsequent telephone follow-up for the care dyads. The nurse will first assess how they manage HF in terms of medication compliance, fluid and dietary control, symptom monitoring and responses in a home visit and clarify their major misconceptions in self-care. This will be followed by five bi-weekly online education sessions on the same topics as the empowerment modules in the De-HF program. | Other: Dyadic education program<br>* The 16-week HF education program comprises a home visit, five bi-weekly online training sessions, and the subsequent telephone follow-up for the care dyads. The nurse will first assess how they manage HF in terms of medication compliance, fluid and dietary control, symptom monitoring and responses in a home visit and clarify their major misconceptions in self-care. This will be followed by five bi-weekly online education sessions on the same topics as the empowerment modules in the De-HF program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Heart Failure Index (SCHFI, v.7.2) | Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. | Baseline | 
| Self-Care Heart Failure Index (SCHFI, v.7.2) | Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. | 16th week | 
| Self-Care Heart Failure Index (SCHFI, v.7.2) | Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. | 24th week | 
| Self-Care Heart Failure Index (SCHFI, v.7.2) | Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. | 32nd week | 
| Minnesota Living with Heart Failure (MLHF) questionnaire | Measure the disease-specific HRQL (primary outcome of the HF patient), covering the physical and emotional health of HF patients. There are 21 items and each item is rated from 0 to 5, with higher scores indicating poor health. | Baseline | 
| Minnesota Living with Heart Failure (MLHF) questionnaire | Measure the disease-specific HRQL (primary outcome of the HF patient), covering the physical and emotional health of HF patients. There are 21 items and each item is rated from 0 to 5, with higher scores indicating poor health. | 16th week | 
| Minnesota Living with Heart Failure (MLHF) questionnaire | Measure the disease-specific HRQL (primary outcome of the HF patient), covering the physical and emotional health of HF patients. There are 21 items and each item is rated from 0 to 5, with higher scores indicating poor health. | 24th week | 
| Minnesota Living with Heart Failure (MLHF) questionnaire | Measure the disease-specific HRQL (primary outcome of the HF patient), covering the physical and emotional health of HF patients. There are 21 items and each item is rated from 0 to 5, with higher scores indicating poor health. | 32nd week | 
| The EuroQoL-5D-5L instruments | Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems, moderate problems, severe problems and unable to) response set, with unable to levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome. | Baseline | 
| The EuroQoL-5D-5L instruments | Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems, moderate problems, severe problems and unable to) response set, with unable to levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome. | 16th week | 
| The EuroQoL-5D-5L instruments | Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems, moderate problems, severe problems and unable to) response set, with unable to levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome. | 24th week | 
| The EuroQoL-5D-5L instruments | Assess the health-related quality of life of the care dyads and to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems, moderate problems, severe problems and unable to) response set, with unable to levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome. | 32nd week | 
| Shared Care Instrument-Revised (SCI-3) | Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. | Baseline | 
| Shared Care Instrument-Revised (SCI-3) | Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. | 16th week | 
| Shared Care Instrument-Revised (SCI-3) | Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. | 24th week | 
| Shared Care Instrument-Revised (SCI-3) | Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. | 32nd week | 
| Control Attitude Scale Revised (CAS-R) | Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. | Baseline | 
| Control Attitude Scale Revised (CAS-R) | Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. | 16th week | 
| Control Attitude Scale Revised (CAS-R) | Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. | 24th week | 
| Control Attitude Scale Revised (CAS-R) | Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. | 32nd week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Self Care, Empowerment, Dyadic, Disease management, Transitional care