Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05806606
Other study ID # DE-HF
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2023
Est. completion date April 1, 2026

Study information

Verified date June 2024
Source The University of Hong Kong
Contact Doris Sau Fung YU, PhD
Phone 39176319
Email dyu1@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 two regional hospital in Hong Kong, with subjects to be recruited from the in-patient setting. They need to have 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 226 care dyads who will be allocated in a 1:1 ratio to receive the DE-HF Program of the 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, 24th week and 32rd week with validated measure.


Recruitment information / eligibility

Status Recruiting
Enrollment 226
Est. completion date April 1, 2026
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - Aged 55 or over - Confirmed medical diagnosis of Heart Failure by a cardiologist of at least 6 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.

Study Design


Intervention

Other:
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.

Locations

Country Name City State
Hong Kong Department of Medicine, Tseung Kwan O Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
The University of Hong Kong Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (24)

Boczor S, Daubmann A, Eisele M, Blozik E, Scherer M. Quality of life assessment in patients with heart failure: validity of the German version of the generic EQ-5D-5L. BMC Public Health. 2019 Nov 6;19(1):1464. doi: 10.1186/s12889-019-7623-2. — View Citation

Buck HG, Harkness K, Wion R, Carroll SL, Cosman T, Kaasalainen S, Kryworuchko J, McGillion M, O'Keefe-McCarthy S, Sherifali D, Strachan PH, Arthur HM. Caregivers' contributions to heart failure self-care: a systematic review. Eur J Cardiovasc Nurs. 2015 F — View Citation

Buck HG, Stromberg A, Chung ML, Donovan KA, Harkness K, Howard AM, Kato N, Polo R, Evangelista LS. A systematic review of heart failure dyadic self-care interventions focusing on intervention components, contexts, and outcomes. Int J Nurs Stud. 2018 Jan;7 — View Citation

Chen S, Zheng S, Wang X, Zhang X, Fa T, Fu L, Zang X, Zhao Y. Linguistic and Psychometric Validation of the Chinese Version of the Control Attitudes Scale-Revised in Patients With Chronic Heart Failure. J Cardiovasc Nurs. 2021 Jul-Aug 01;36(4):349-356. do — View Citation

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-2013-30485 — View Citation

Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1. — View Citation

Ho CC, Clochesy JM, Madigan E, Liu CC. Psychometric evaluation of the Chinese version of the Minnesota Living with Heart Failure Questionnaire. Nurs Res. 2007 Nov-Dec;56(6):441-8. doi: 10.1097/01.NNR.0000299849.21935.c4. — View Citation

Jaarsma T, Hill L, Bayes-Genis A, La Rocca HB, Castiello T, Celutkiene J, Marques-Sule E, Plymen CM, Piper SE, Riegel B, Rutten FH, Ben Gal T, Bauersachs J, Coats AJS, Chioncel O, Lopatin Y, Lund LH, Lainscak M, Moura B, Mullens W, Piepoli MF, Rosano G, S — View Citation

Jonkman NH, Westland H, Groenwold RH, Agren S, Atienza F, Blue L, Bruggink-Andre de la Porte PW, DeWalt DA, Hebert PL, Heisler M, Jaarsma T, Kempen GI, Leventhal ME, Lok DJ, Martensson J, Muniz J, Otsu H, Peters-Klimm F, Rich MW, Riegel B, Stromberg A, Ts — View Citation

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. — View Citation

Rahmani A, Vahedian-Azimi A, Sirati-Nir M, Norouzadeh R, Rozdar H, Sahebkar A. The Effect of the Teach-Back Method on Knowledge, Performance, Readmission, and Quality of Life in Heart Failure Patients. Cardiol Res Pract. 2020 Nov 23;2020:8897881. doi: 10. — View Citation

Riegel B, Barbaranelli C, Carlson B, Sethares KA, Daus M, Moser DK, Miller J, Osokpo OH, Lee S, Brown S, Vellone E. Psychometric Testing of the Revised Self-Care of Heart Failure Index. J Cardiovasc Nurs. 2019 Mar/Apr;34(2):183-192. doi: 10.1097/JCN.00000 — View Citation

Ryan CJ, Bierle RS, Vuckovic KM. The Three Rs for Preventing Heart Failure Readmission: Review, Reassess, and Reeducate. Crit Care Nurse. 2019 Apr;39(2):85-93. doi: 10.4037/ccn2019345. Erratum In: Crit Care Nurse. 2019 Oct;39(5):12. — View Citation

Sebern M, Riegel B. Contributions of supportive relationships to heart failure self-care. Eur J Cardiovasc Nurs. 2009 Jun;8(2):97-104. doi: 10.1016/j.ejcnurse.2008.07.004. Epub 2008 Aug 15. — View Citation

Sebern MD, Woda A. Shared care dyadic intervention: outcome patterns for heart failure care partners. West J Nurs Res. 2012 Apr;34(3):289-316. doi: 10.1177/0193945911399088. Epub 2011 Mar 7. — View Citation

Sebern MD. Refinement of the Shared Care Instrument-Revised: a measure of a family care interaction. J Nurs Meas. 2008;16(1):43-60. doi: 10.1891/1061-3749.16.1.43. — View Citation

Srisuk N, Cameron J, Ski CF, Thompson DR. Randomized controlled trial of family-based education for patients with heart failure and their carers. J Adv Nurs. 2017 Apr;73(4):857-870. doi: 10.1111/jan.13192. Epub 2016 Nov 30. — View Citation

Strachan PH, Currie K, Harkness K, Spaling M, Clark AM. Context matters in heart failure self-care: a qualitative systematic review. J Card Fail. 2014 Jun;20(6):448-55. doi: 10.1016/j.cardfail.2014.03.010. Epub 2014 Apr 13. — View Citation

Tidermark J, Bergstrom G, Svensson O, Tornkvist H, Ponzer S. Responsiveness of the EuroQol (EQ 5-D) and the SF-36 in elderly patients with displaced femoral neck fractures. Qual Life Res. 2003 Dec;12(8):1069-79. doi: 10.1023/a:1026193812514. — View Citation

Vellone E, Rebora P, Ausili D, Zeffiro V, Pucciarelli G, Caggianelli G, Masci S, Alvaro R, Riegel B. Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial. ESC Heart Fail. 2020 Jun;7(3):1309- — View Citation

Vickerstaff V, Ambler G, King M, Nazareth I, Omar RZ. Are multiple primary outcomes analysed appropriately in randomised controlled trials? A review. Contemp Clin Trials. 2015 Nov;45(Pt A):8-12. doi: 10.1016/j.cct.2015.07.016. Epub 2015 Jul 26. — View Citation

Wong EL, Cheung AW, Wong AY, Xu RH, Ramos-Goni JM, Rivero-Arias O. Normative Profile of Health-Related Quality of Life for Hong Kong General Population Using Preference-Based Instrument EQ-5D-5L. Value Health. 2019 Aug;22(8):916-924. doi: 10.1016/j.jval.2 — View Citation

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 — View Citation

Yu DS, Li PW, Zhang F, Cheng ST, Ng TK, Judge KS. The effects of a dyadic strength-based empowerment program on the health outcomes of people with mild cognitive impairment and their family caregivers: a randomized controlled trial. Clin Interv Aging. 201 — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Care Heart Failure Index (SCHFI, v.7.2) Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. Baseline
Primary Self-Care Heart Failure Index (SCHFI, v.7.2) Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. 16th week
Primary Self-Care Heart Failure Index (SCHFI, v.7.2) Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. 24th week
Primary Self-Care Heart Failure Index (SCHFI, v.7.2) Measure the self-care maintenance, self-care management, and symptom perception of the HF patients. There are 28 questions are rated from 1 to 5, and one question are rated from 0 to 5. The three subscale scores are transformed to 0-100, with higher scores indicating better self-care attributes. 32nd week
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Shared Care Instrument-Revised (SCI-3) Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. Baseline
Primary Shared Care Instrument-Revised (SCI-3) Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. 16th week
Primary Shared Care Instrument-Revised (SCI-3) Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. 24th week
Primary Shared Care Instrument-Revised (SCI-3) Measure the level of shared care in terms of communication, decision-making, and reciprocity of care dyads. Each item is rated from zero to five (completely agree, mostly agree, slightly agree, slightly disagree, mostly disagree, and completely disagree), with higher scores representing better shared care. 32nd week
Primary Control Attitude Scale Revised (CAS-R) Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. Baseline
Primary Control Attitude Scale Revised (CAS-R) Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. 16th week
Primary Control Attitude Scale Revised (CAS-R) Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. 24th week
Primary Control Attitude Scale Revised (CAS-R) Measure the perceived control in disease management. Each item was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) and summed to create a total score after two negative items were reverse coded. The possible total score ranges from 8 to 40 with a higher score indicating higher perceived controllability. 32nd week
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy