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

Nanyang Technological University

Status: Enrolling

Conditions: End Stage Renal Failure on Dialysis; End Stage Renal Disease; End Stage Renal Disease on Dialysis; End Stage Kidney Disease

Treatments: Behavioral: HED-Start

Study type: Interventional

Funder types: Other

Identifiers

NCT04774770

NKFRC/2018/01/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

HED-Start Intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: HED-Start

Standard care arm

No Intervention group

Description:

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