Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05864469
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2023-05-09
Brief Title:
A Psychosocial Dyadic Programme for Patients With Heart Failure and Their Family Caregivers
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
The Effects of a Psychosocial Dyadic Intervention on the Mutuality Psychological and Quality of Life Outcomes of Patients With Heart Failure and Their Family Caregivers A Mixed-methods Study
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall aim of the study is to evaluate the effects of a psychosocial dyadic intervention on mutuality psychological strengths ie resilience and self-compassion psychological distress ie anxiety and depression and QoL outcomes of HF patients and caregivers The HF patient-caregiver dyads will be randomly allocated to the intervention group to receive a 12-week relationship-focused psychosocial dyadic intervention or to the control group to receive the usual care provided by the clinical team in the hospital
Detailed Description:
Heart failure HF is the terminal stage of various cardiovascular diseases HF patient-caregiver dyads who need to undertake the majority of HF care responsibility in the community often experience a challenging adaptive process There is a desperate need to develop and evaluate psychosocial dyadic interventions in HF patients and caregivers as well as examine the working mechanism of such interventions This sequential mixed-methods study consists of a single-blinded two-arm randomized controlled trial RCT and a qualitative study The dyads will be randomly allocated in a 11 ratio to the intervention group to receive a 12-week relationship-focused psychosocial dyadic programme or to the control group to receive the usual care provided by the clinical team in the hospital Besides an empowerment-based approach will be employed in this programme to work together with patients and caregivers to set goals and develop an action plan to facilitate goal attainment For the patients Mutuality Scale Connor-Davidson Resilience Scale Self-Compassion Scale Short Form Minnesota Living with Heart Failure Questionnaire and Hospital Anxiety and Depression Scale will be administered at baseline immediate and 3-month post-intervention For the caregivers the Mutuality Scale Connor-Davidson Resilience Scale Self-Compassion Scale Short Form Family Caregiver Quality of Life Scale and Hospital Anxiety and Depression Scale will be administered at baseline immediate and 3-month post-intervention A pilot study will be conducted to determine the feasibility acceptability and preliminary effect of the intervention first Afterwards a full-scale mixed-methods study will be conducted to evaluate the effects of the intervention and the mechanism underlying the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None