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

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

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.

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.

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

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

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.

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

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.

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.

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.

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.

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.

Self-Efficacy for Managing Chronic Disease 6-item Scale. The overall scale score ranges from 1 to 10. Higher scores reflect greater self-efficacy.

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.

2-item Connor-Davidson Resilience Scale (CD-RISC-2). The CD-RISC-2 score ranges from 0 to 8. Higher scores indicate greater resilience.

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.

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)

All deidentified IPD that underlie results in a publication will be available upon reasonable request.

Griva K, Chia JMX, Goh ZZS, Wong YP, Loei J, Thach TQ, Chua WB, Khan BA. Effectiveness of a brief positive skills intervention to improve psychological adjustment in patients with end-stage kidney disease newly initiated on haemodialysis: protocol for a randomised controlled trial (HED-Start). BMJ Open. 2021 Sep 21;11(9):e053588. doi: 10.1136/bmjopen-2021-053588.