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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774770
• Other study ID #: NKFRC/2018/01/02
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Nanyang Technological University
• Contact: Konstadina Griva, PhD
• Phone: +6569047348
• Email: konstadina.griva[@]ntu.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: June 30, 2024
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Kidney Disease
• End Stage Renal Disease
• End Stage Renal Disease on Dialysis
• End Stage Renal Failure on Dialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Singapore	National Kidney Foundation Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Nanyang Technological University	National Kidney Foundation, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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