NCT03200730: FDI

A Novel Family Dignity Intervention (FDI) for Asian Palliative Care

Status unknown NA Last updated 29 March 2018

What this trial tests

NA trial testing Family Dignity Intervention group in Palliative Care in 252 participants. Status unknown.

Timeline

1 July 2017

Primary endpoint
30 January 2020

30 January 2020

Quick facts

Lead sponsor	Nanyang Technological University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	252
Start date	1 July 2017
Primary completion	30 January 2020
Estimated completion	30 January 2020
Sites	2 locations across Singapore

Drugs / interventions tested

• Family Dignity Intervention group

Conditions studied

• Palliative Care — all drugs for Palliative Care →

Sponsor

Nanyang Technological University

Who can join

60 and older, any sex, with Palliative Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: The lack of a holistic approach to palliative care can lead to a fractured sense of dignity at the end of life, resulting in depression, hopelessness, feelings of being a burden to others, and the loss of will to live among terminally-ill patients. Building on the clinical foundation of Dignity Therapy, together with the empirical understanding of dignity-related concerns of Asian families facing terminal-illness, a novel Family Dignity Intervention (FDI) has been developed for Asia palliative care. FDI comprises a recorded interview with a patient and his/her primary family caregiver, which is transcribed, edited into a legacy document, and return to the dyads for sharing with the rest of the patient's family. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of FDI in reducing psychosocial, emotional, spiritual, and psychophysiological distress in community-dwelling and in-patient Asian older terminally-ill patients and their families living in Singapore.

Methods/Design: An open-label multicentre randomized controlled trial. 126 patient-family dyads are randomly allocated to one of two groups: (i) intervention group (FDI offered in addition to standard psychological care), and (ii) control group (standard psychological care). Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline, three days and two week after intervention, and during an exit interview with family caregivers at two month post bereavement. Primary outcome measures include sense of dignity for patients and psychological distress for caregivers. Secondary outcomes include meaning in life, quality of life, spirituality, hopefulness, perceived support and psychophysiological well-being, as well as bereavement outcomes for caregivers. Qualitative data are analyzed using Framework method.

Discussion: To date, there is no available palliative care intervention for dignity enhancement in Asia. This first-of-its kind study develops and tests an evidence-based, family-driven psycho-socio-spiritual intervention for enhancing dignity and wellbeing among Asian patients and families facing mortality. It address a critical gap in the provision of holistic palliative care. The expected outcomes will contribute to advancements in both theories and practices of palliative care for Singapore and other Asian communities around the world.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial.
   Ho AHY, Car J, Ho MR, Tan-Ho G, et al · · 2017 · cited 29× · PMID 29202863 · DOI 10.1186/s13063-017-2325-5