Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT05806606
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2023-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect and Cost Effectiveness of a Dyadic Empowerment-based Heart Failure Management Program for Self-care
Sponsor:
The University of Hong Kong
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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 three regional hospital in Hong Kong, with subjects to be recruited from the in-patient setting.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: