Clinical trial NCT04774770: HED-Start: Evaluating a Positive Skills Intervention for Patients New on Haemodialysis
Official title: HED-Start: A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
End Stage Renal Failure on Dialysis
End Stage Renal Disease
End Stage Kidney Disease
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, Singapore
First posted: 2021-03-01
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Anxiety and Depression (HADS) scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
Secondary outcomes:
measure: Change in Quality of life (WHOQOL-BREF) scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in kidney disease-related quality of life (KDQOL-SF) scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in Illness Perception scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in Positive and Negative Affect scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in Self-Efficacy for Managing Chronic Disease 6-item Scale scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in Benefit finding in hemodialysis (BFS) scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in Resilience scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
measure: Change in Health Education Impact Questionnaire scores from baseline
timeFrame: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Kidney Foundation Singapore
Study officials:
affiliation: Nanyang Technological University
name: Konstadina Griva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.