Viewing Study NCT04774770



Ignite Creation Date: 2024-05-06 @ 3:51 PM
Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04774770
Status: RECRUITING
Last Update Posted: 2024-04-15
First Post: 2021-02-23

Brief Title: HED-Start Evaluating a Positive Skills Intervention for Patients New on Haemodialysis
Sponsor: Nanyang Technological University
Organization: Nanyang Technological University

Study Overview

Official Title: HED-Start A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis
Status: RECRUITING
Status Verified Date: 2024-04
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: Hemodialysis patients often experience barriers and misperceptions that hinder adjustment to life on dialysis This study seeks to explore a group-based intervention titled HED-Start developed to improve self-care and emotional wellbeing among incident hemodialysis patients
Detailed Description: There are potentially modifiable psychosocial barriers and misperceptions about life on dialysis that hinder adjustment outcomes It is hypothesized that these may include poor understanding on what is needed or how to implement treatment principles misperceptions related to disease and treatment catastrophizing beliefs about impact of dialysis and low level of confidence on ability to manage treatment regime and renegotiate life roles as a dialysis patient

This study seeks to explore the feasibility and acceptability of implementing a two-arm parallel randomized controlled trial of a group-based intervention titled HED-Start HED-Start is specifically developed to reduce psychological distress and support self-care and self-management outcomes in incident hemodialysis patients

Drawing on self-management and motivational interviewing principles paradigm the HED-Start program aims to facilitate acquisition of skills and knowledge to support and improve self-care and emotional adjustment outcomes

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