Effect and Cost Effectiveness of a Dyadic Empowerment-based Heart Failure Management Program for Self-care
NCT ID: NCT05806606
Last Updated: 2025-12-03
Study Results
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Basic Information
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RECRUITING
NA
232 participants
INTERVENTIONAL
2023-04-17
2026-06-01
Brief Summary
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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.
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Detailed Description
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The subjects need to be aged 18 or above, with 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 232 care dyads who will be allocated in a 1:1 ratio to receive the DE-HF Program of the HF dyadic 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 16th week, 24th week and 32rd week with validated measure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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 by computer generated sequence in a 1:1 allocation ratio to receive either the De-HF or the HF dyadic educational program. To ensure double blinding, the dyads will not know whether they are participating in the test or control intervention, and the outcome measurement will be conducted by another research assistant without knowing the assigned group of the participants.
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Confirmed medical diagnosis of Heart Failure by a cardiologist of at least 3 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
* With end-stage renal disease relying on hemodialysis rather than HF medications to regulate fluid volume.
18 Years
ALL
No
Sponsors
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Hospital Authority, Hong Kong
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
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Prof. Yu, Doris Sau Fung
Professor
Principal Investigators
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Doris Sau Fung YU, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Department of Medicine, Tseung Kwan O Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Yu DS, Lee DT, Stewart S, Thompson DR, Choi KC, Yu CM. Effect of Nurse-Implemented Transitional Care for Chinese Individuals with Chronic Heart Failure in Hong Kong: A Randomized Controlled Trial. J Am Geriatr Soc. 2015 Aug;63(8):1583-93. doi: 10.1111/jgs.13533.
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Hospital Authority Statistical Report 2016-2017
Other Identifiers
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DE-HF
Identifier Type: -
Identifier Source: org_study_id
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