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

Sponsor

The University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05806606

Collaborator

Hospital Authority, Hong Kong (Other)

226

Enrollment

Arms

35.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Self Care Empowerment Transitional Care Disease Management	Other: Dyadic empowerment based heart failure management program Other: Dyadic education program	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

It is a double-blind study. A research nurse will identify potential subjects from the Clinical Management System, and will screen for the patient's cognitive function and NYHA status. Eligible patients and their primary carers will be invited to participate during their hospital stay. After obtaining their written informed consent, the research nurse will collect their baseline demographic data and administer the following outcome measures in a face-to-face interview. The care dyads will be randomized to receive either the De-HF or educational program in an allocation ratio of 1:1. To ensure double blinding, the dyads will not know whether they are participating in the test or control intervention. The assigned intervention will be commenced within 2 weeks of the baseline measure. Post-test outcome evaluation will take place at the 16th week (post-intervention), 24th week, and 32nd week.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 17, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dyadic Empowerment-based Heart Failure program (De-HF) 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 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.
Active Comparator: Dyadic education program 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 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.

Arm

Intervention/Treatment

Experimental: Dyadic Empowerment-based Heart Failure program (De-HF)

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

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.

Active Comparator: Dyadic education program

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

Outcome Measures

Primary Outcome Measures

Self-Care Heart Failure Index (SCHFI, v.7.2) [Baseline]
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.
Self-Care Heart Failure Index (SCHFI, v.7.2) [16th week]
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.
Self-Care Heart Failure Index (SCHFI, v.7.2) [24th week]
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.
Self-Care Heart Failure Index (SCHFI, v.7.2) [32nd week]
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.
Minnesota Living with Heart Failure (MLHF) questionnaire [Baseline]
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.
Minnesota Living with Heart Failure (MLHF) questionnaire [16th week]
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.
Minnesota Living with Heart Failure (MLHF) questionnaire [24th week]
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.
Minnesota Living with Heart Failure (MLHF) questionnaire [32nd week]
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.
The EuroQoL-5D-5L instruments [Baseline]
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.
The EuroQoL-5D-5L instruments [16th week]
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.
The EuroQoL-5D-5L instruments [24th week]
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.
The EuroQoL-5D-5L instruments [32nd week]
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.
Shared Care Instrument-Revised (SCI-3) [Baseline]
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.
Shared Care Instrument-Revised (SCI-3) [16th week]
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.
Shared Care Instrument-Revised (SCI-3) [24th week]
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.
Shared Care Instrument-Revised (SCI-3) [32nd week]
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.
Control Attitude Scale Revised (CAS-R) [Baseline]
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.
Control Attitude Scale Revised (CAS-R) [16th week]
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.
Control Attitude Scale Revised (CAS-R) [24th week]
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.
Control Attitude Scale Revised (CAS-R) [32nd week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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