HED-Start: A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Change in Anxiety and Depression (HADS) scores from baseline
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Care providers (dialysis nurses) and outcomes assessors (research staff conducting the baseline and follow-up questionnaires) will be blinded to participant allocation.
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Change in Anxiety and Depression (HADS) scores from baseline
Time Frame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
Hospital Anxiety and Depression Scale (HADS). The HADS comprises two subscales (anxiety; depression) and can be totaled to produce an overall scale score. Scores range from 0 to 21 for each subscale, and from 0 to 42 for the overall score. Higher scores are indicative of worse anxiety and depression symptoms.
Secondary Outcomes
- Change in Illness Perception scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Positive and Negative Affect scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Self-Efficacy for Managing Chronic Disease 6-item Scale scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in kidney disease-related quality of life (KDQOL-SF) scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Quality of life (WHOQOL-BREF) scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Benefit finding in hemodialysis (BFS) scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Resilience scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Health Education Impact Questionnaire scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
Investigators
Konstadina Griva
Associate Professor of Health Psychology and Behavioural Medicine
Nanyang Technological University