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

Not Applicable

Recruiting

• Conditions: End Stage Renal Failure on Dialysis; End Stage Kidney Disease; End Stage Renal Disease; End Stage Renal Disease on Dialysis
• Interventions: Behavioral: HED-Start

• Registration Number: NCT04774770
• Lead Sponsor: Nanyang Technological University

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 Timeline

• Study Start: 2021-01-05
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2022-10-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HED-Start Intervention arm	HED-Start	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.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety and Depression (HADS) scores from baseline	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 Outcome Measures

Name	Time	Method
Change in Illness Perception scores from baseline	Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization	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.
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	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.
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	Self-Efficacy for Managing Chronic Disease 6-item Scale. The overall scale score ranges from 1 to 10. Higher scores reflect greater self-efficacy.
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	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.
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	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.
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	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.
Change in Resilience scores from baseline	Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization	2-item Connor-Davidson Resilience Scale (CD-RISC-2). The CD-RISC-2 score ranges from 0 to 8. Higher scores indicate greater resilience.
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	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.

Trial Locations

Locations (1)

National Kidney Foundation Singapore; 🇸🇬 Singapore, Singapore