A program to help new hemodialysis patients adjust to treatment
HED-Start: A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis
NA · Nanyang Technological University · NCT04774770
This study is testing a new support program to help people who just started hemodialysis feel more comfortable and confident in managing their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Nanyang Technological University (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04774770 on ClinicalTrials.gov |
What this trial studies
This study evaluates a group-based intervention called HED-Start, designed to improve self-care and emotional wellbeing among patients who have recently started hemodialysis. It addresses psychosocial barriers and misperceptions that can hinder adjustment to life on dialysis. The intervention employs self-management and motivational interviewing principles to enhance patients' understanding and confidence in managing their treatment. The study will assess the feasibility and acceptability of this approach through a randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who have been diagnosed with end-stage kidney disease and are on hemodialysis for less than 90 days.
Not a fit: Patients who are unable to provide informed consent, have cognitive impairments, or are nearing end-of-life care may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the emotional and self-care outcomes for new hemodialysis patients.
How similar studies have performed: While similar psychosocial interventions have shown promise in improving patient outcomes, the specific approach of HED-Start is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Singapore
- National Kidney Foundation Singapore — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Konstadina Griva, PhD — Nanyang Technological University
- Study coordinator: Konstadina Griva, PhD
- Email: konstadina.griva@ntu.edu.sg
- Phone: +6569047348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Renal Disease on Dialysis, End Stage Renal Failure on Dialysis, End Stage Renal Disease, End Stage Kidney Disease