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

The University of Hong Kong (HKU)

Status: Enrolling

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

Treatments: Other: Dyadic education program; Other: Dyadic empowerment based heart failure management program

Study type: Interventional

Funder types: Other

Identifiers

NCT05806606

DE-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Dyadic empowerment based heart failure management program

Dyadic education program

Active Comparator group

Description:

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.

Treatment:

Other: Dyadic education program