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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease; End Stage Kidney Disease; End Stage Renal Failure on Dialysis; End Stage Renal Disease on Dialysis
• Intervention / Treatment: Behavioral: HED-Start

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 Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Konstadina Griva, PhD; Phone Number: +6569047348; Email: konstadina.griva@ntu.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National Kidney Foundation Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanyang Technological University
• Collaborators: National Kidney Foundation, Singapore
• Investigators: Principal Investigator: Konstadina Griva, PhD, Nanyang Technological University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): October 7, 2022
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: NKFRC/2018/01/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All deidentified IPD that underlie results in a publication will be available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No