Clinical Trials Logo

Clinical Trial Summary

To pilot a culturally adapted version of ENABLE (6-month program) for Heart Failure (HF) patients and caregivers in the inpatient and outpatient setting in Singapore. The investigators aim to determine the feasibility of trial procedures and assess the acceptability and preliminary efficacy of ENABLE with a randomized wait-list controlled trial design.

Clinical Trial Description

Palliative care improves quality of life (QOL) of patients and their caregivers. The ENABLE (Educate, Nurture, Advise Before Life Ends) intervention is a novel, nurse-led, structured, palliative care coaching program, developed in the United States for patients (and caregivers of patients) facing serious illnesses. It aims to empower patients and caregivers to manage their problems, prepare for the future, and has showed beneficial impact on patient and caregiver QOL. The ENABLE coaching program is a potentially scalable means of delivering palliative care to a large population; as compared to the current local model of palliative care provision, which uses a resource intensive multidisciplinary care model that is not easily scalable and therefore unlikely to meet the growing needs of HF patients and caregivers locally. However, it is unclear if the ENABLE HF program will be culturally acceptable and efficacious in Singapore, in view of differing socio-cultural attitudes and expectations regarding healthcare and treatments, decision making and care planning. Overall aim - To pilot a culturally adapted version of ENABLE (6-month program) for HF patients and caregivers in the inpatient and outpatient setting in Singapore. Specific Aim 1 - Assessment of feasibility of trial procedures in the local HF population. Intervention arm participants will start on ENABLE after randomization, while wait-list participants will start on ENABLE after 6 months. The investigators will evaluate the percentage of eligible participant dyads who consent to participate and who are able to complete the ENABLE program. The investigators will also explore the percentage completion rate of patient and caregiver reported outcome measures. - Hypothesis: The investigators hypothesize a-priori that 80% of eligible participant dyads will consent to participate and 80% of eligible participant dyads will be able to complete the ENABLE program. Specific aim 2 - Assessment of acceptability of ENABLE. The investigators aim to study the acceptability of ENABLE to all patient-caregiver dyads. This will be done through evaluating the total scores of a satisfaction survey of all participants at the end of ENABLE. - Hypothesis: The investigators hypothesize that at least 80% of all participants will find the ENABLE program acceptable. Specific aim 3 - Assessment of the possible efficacy of ENABLE. The investigators will evaluate whether there is an efficacy signal that indicates ENABLE may improve patient QOL in the local HF context. - Hypothesis: The investigators hypothesize that patient participants randomized to the intervention arm will have more improvement in their mean QOL scores after 6 months as compared to the wait-list control group. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05211882
Study type Interventional
Source National Cancer Centre, Singapore
Contact Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS
Phone +65 64368183
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date February 7, 2022
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study
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
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Not yet recruiting NCT05465213 - Real-world Dapagliflozin Treatment in Patients With Heart Failure in Portugal (EVOLUTION-HF)
Not yet recruiting NCT05407662 - A Study Using Surveys to Learn More About Treatment With Steroidal Mineralocorticoid Receptor Antagonists, How They Are Used, What Side Effects They Have, and How Satisfied People Who Receive Them Are in the US
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT04549181 - Problem-Solving for Rural Heart Failure Dyads N/A
Completed NCT02748876 - Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy N/A
Completed NCT05057364 - Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure N/A
Completed NCT03294512 - Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform N/A
Completed NCT03300791 - Predictive Models of Readmission in Heart Failure
Enrolling by invitation NCT04676100 - International CR Registry
Terminated NCT03565328 - The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects Phase 2
Terminated NCT04066738 - Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy N/A
Enrolling by invitation NCT04573166 - Personalized Atrial Septostomy for Heart Failure N/A
Recruiting NCT04537104 - Remote Monitoring in Patients With Heart Failure