Clinical trial NCT05211882: ENABLE (Educate, Nurture, Advise, Before Life Ends) Intervention for Heart Failure (HF) Patients and Their Caregivers in Singapore
Official title: Pilot Wait-list Randomized Controlled Trial of the ENABLE (Educate, Nurture, Advise, Before Life Ends) Intervention for Heart Failure (HF) Patients and Their Caregivers in Singapore
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Palliative care
Patients
Caregivers
Distress thermometer (DT)
Integrated Palliative Care Outcome Scale (IPOS)
ENABLE (Educate, Nurture, Advise, Before Life Ends)
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: National Medical Research Council (NMRC), Singapore
First posted: 2022-01-27
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for patients:

  1. 21 years or older.
  2. Able to communicate in English or Chinese.
  3. Have a diagnosis of HF (stage C or D) by the American College of Cardiology guidelines and be of New York Heart Association (NYHA) stage 2, 3 or 4 functional statuses.
  4. Have an expected prognosis of at least 6 months.
  5. Be on disease directed HF management.
  6. Have had a hospitalization event within 6 months prior to recruitment.
* Inclusion criteria for caregivers:

  1. 21 years or older.
  2. Able to communicate in English or Chinese.
  3. Is a direct family caregiver of the patient.

Exclusion Criteria:

* Exclusion criteria for patients:

  1. Patients who are unable to give informed consent
  2. Patients who are already known to a palliative care service.
* Exclusion criteria for caregivers:

  1. Caregivers who are unable to give informed consent.
  2. Caregivers who are domestic helpers.

Primary outcomes:
measure: Feasibility of trial procedures - percentage of patients and caregivers that are recruited, successfully randomized, and able to complete the ENABLE program
timeFrame: 6 months.
measure: Acceptability of ENABLE program - through completion of the client satisfaction questionnaire (CSQ-4)
timeFrame: 6 months.
measure: The possible efficacy of the ENABLE program- through evaluating change in patient quality of life (QOL) at 6 months as compared to baseline (assessed using the Kansas City Cardiomyopathy Questionnaire - KCCQ)
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS
role: PRINCIPAL_INVESTIGATOR
References: