HED-Start: Evaluating a Positive Skills Intervention for Patients New on Haemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease on Dialysis End Stage Renal Failure on Dialysis End Stage Renal Disease End Stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Care providers (dialysis nurses) and outcomes assessors (research staff conducting the baseline and follow-up questionnaires) will be blinded to participant allocation.

Study Groups

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HED-Start Intervention arm

Participants assigned to the intervention arm will undergo 4 sessions of the HED-Start program. Each session is 2 hours long and will be conducted fortnightly.

Group Type EXPERIMENTAL

HED-Start

Intervention Type BEHAVIORAL

The HED-Start Program is a cognitive-behavioral intervention based on self-management and motivational interviewing principles.

Standard care arm

Participants assigned to the standard care arm will proceed with routine standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HED-Start

The HED-Start Program is a cognitive-behavioral intervention based on self-management and motivational interviewing principles.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with end-stage kidney disease (ESKD) and established on hemodialysis with the National Kidney Foundation Singapore (NKF) for fewer than 90 days
* At least 21 years old
* Proficient in spoken and written English or Mandarin

Exclusion Criteria

* Unwilling or unable to give informed consent or refuse to be randomized
* Have cognitive impairments or psychiatric conditions that preclude consent
* Are currently involved in other intervention trials
* Are failing on dialysis and approaching end of life (supportive/palliative care pathway)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No