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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Medicine, Tseung Kwan O Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Doris Sau Fung YU, PhD
dyu1@hku.hk
39176319
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 232
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Authority, Hong Kong
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov