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

NCT04774770 | Recruiting

• 1 other identifier: NKFRC/2018/01/02
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Change in Illness Perception scores from baseline

  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

  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

  Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization

Study Arms (2)

HED-Start Intervention arm

EXPERIMENTAL

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

Standard care arm

NO INTERVENTION

Participants assigned to the standard care arm will proceed with routine standard care.

Interventions

HED-Start BEHAVIORAL

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

HED-Start Intervention arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanyang Technological University: lead
• National Kidney Foundation, Singapore: collaborator

Study Sites (1)

National Kidney Foundation Singapore

Singapore, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 34548369 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konstadina Griva, PhD

  Nanyang Technological University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstadina Griva, PhD

CONTACT

+6569047348; konstadina.griva@ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care providers (dialysis nurses) and outcomes assessors (research staff conducting the baseline and follow-up questionnaires) will be blinded to participant allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Psychology and Behavioural Medicine

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: January 5, 2021
• Primary Completion: October 7, 2022
• Study Completion: June 30, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

SG (1)