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

NCT05806606 | Recruiting DMC

• 1 other identifier: DE-HF
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Self Care; Empowerment; Transitional Care; Disease Management

Keywords

Heart Failure; Self Care; Empowerment; Dyadic; Disease management; Transitional care

Outcome Measures

Primary Outcomes (8)

• 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

Secondary Outcomes (12)

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  Baseline

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  16th week

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  24th week

• Self-Care Heart Failure Index (SCHFI, v.7.2)

  32nd week

• Shared Care Instrument-Revised (SCI-3)

  Baseline

Study Arms (2)

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

EXPERIMENTAL

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

Dyadic education program

ACTIVE COMPARATOR

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

Interventions

Dyadic empowerment based heart failure management program OTHER

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 program (De-HF)

Dyadic education program OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above
• 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

You may not qualify if:

• Not living with primary caregiver
• With end-stage renal disease relying on hemodialysis rather than HF medications to regulate fluid volume.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

Department of Medicine, Tseung Kwan O Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (24)

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• Clark AM, Spaling M, Harkness K, Spiers J, Strachan PH, Thompson DR, Currie K. Determinants of effective heart failure self-care: a systematic review of patients' and caregivers' perceptions. Heart. 2014 May;100(9):716-21. doi: 10.1136/heartjnl-2013-304852. Epub 2014 Feb 18.

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  PMID: 32343483 RESULT

• Lyons KS, Lee CS. The Theory of Dyadic Illness Management. J Fam Nurs. 2018 Feb;24(1):8-28. doi: 10.1177/1074840717745669. Epub 2018 Jan 20.

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Related Links

• Hospital Authority Statistical Report 2016-2017

MeSH Terms

Conditions

Heart Failure; Empowerment

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Doris Sau Fung YU, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Sau Fung YU, PhD

CONTACT

39176319; dyu1@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It is a double-blind study. A research nurse will identify potential subjects from the Clinical Management System. 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: April 17, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)