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

Study Overview
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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.

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.

Official Title
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HED-Start: A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis

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

Intervention / Treatment
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* Behavioral: HED-Start


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HED-Start Intervention arm<br>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. | Behavioral: HED-Start<br>* The HED-Start Program is a cognitive-behavioral intervention based on self-management and motivational interviewing principles.<br>|
| No Intervention: Standard care arm<br>Participants assigned to the standard care arm will proceed with routine standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety and Depression (HADS) scores from baseline | 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. | Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life (WHOQOL-BREF) scores from baseline | World Health Organization Quality of Life instrument (WHOQOL-BREF). Two global items (overall quality of life; general health) and two subscales (psychological health; social relationships) from the WHOQOL-BREF are used. Global scores range from 1 to 5, while subscale scores range from 4 to 20. Higher scores indicate better quality of life. | 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 | Kidney Disease Quality of Life instrument (KDQOL-SF). The Burden of Kidney Disease subscale from the KDQOL-SF will be administered. Scores range from 0 to 100, with a higher score reflecting better quality of life. | Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization | 
| Change in Illness Perception scores from baseline | Brief Illness Perception Questionnaire (BIPQ). The BIPQ consists of 8 subscales (i.e., Consequence, Timeline, Identity, Personal Control, Treatment Control, Concern, Coherence, and Emotional Representation). Subscale scores range from 0 to 10, with higher scores reflective of more negative illness perceptions. | 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 | Scale of Positive and Negative Experience (SPANE). The SPANE comprises 6 items assessing positive affect and 6 items assessing negative affect. Subscale scores range from 6 to 30. Higher scores in the Positive and Negative affect subscale indicate greater positive and negative affect respectively. | 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 | Self-Efficacy for Managing Chronic Disease 6-item Scale. The overall scale score ranges from 1 to 10. Higher scores reflect greater self-efficacy. | 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 | Benefit Finding Scale (BFS). Two subscales (personal growth; acceptance) and an overall score can be computed. All scores range from 1 to 4, with a higher score reflecting a greater extent of benefit finding. | Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization | 
| Change in Resilience scores from baseline | 2-item Connor-Davidson Resilience Scale (CD-RISC-2). The CD-RISC-2 score ranges from 0 to 8. Higher scores indicate greater resilience. | 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 | Health Education Impact Questionnaire (heiQ). Six subscales from the heiQ (Positive and Active Engagement in Life, Skill and Technique Acquisition, Constructive Attitudes and Approaches, Self-Monitoring and Insight, Health Services Navigation, and Social Integration and Support) will be used to assess other self-management skills. Scores range from 1 to 4. Higher scores indicate greater proficiency with the relevant skill domain. | Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization |