Original InvestigationHemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis
Section snippets
Study Design
The study methodology has been detailed elsewhere.13 In brief, the study was a parallel-group, blinded, cluster-randomized controlled trial comparing HEDSMART to usual care. Ethics approval was received from the National University of Singapore Institutional Review Board, and written informed consent was obtained from study participants.
Setting and Participants
Patients were recruited from 14 of the 24 dialysis centers run by the National Kidney Foundation Singapore (NKF Singapore), a nonprofit charitable organization
Sample Characteristics
A total of 956 dialysis patients receiving care at the participating dialysis centers were assessed for eligibility. Of these participants, 532 (55.6%) were deemed eligible. A total of 259 (48.7%) provided consent and 235 (44.2%) completed the baseline assessment and were subsequently randomly assigned (based on dialysis shift) to the HED-SMART intervention (n = 101) or usual care (n = 134; Fig 1). Patients’ characteristics were similar between arms at baseline (Table 1).
Retention and Completion Rates
Overall retention through
Discussion
The current study reports results of a cluster-randomized controlled trial to explore the effectiveness of a self-management intervention for hemodialysis patients in comparison to usual care. The HED-SMART program was found to reach a representative proportion of those contacted and considered to be eligible and had a good retention rate.
There was evidence of some improvement on clinical outcomes for HED-SMART relative to baseline. These were consistently noted at 3 months postintervention, in
Acknowledgements
The authors thank the research assistants and graduate students who assisted in this project (including Dr Tonia Griva [deceased], Mr Augustine W.C. Kang, and Ms June Lim), the participating health care professionals at the NKF Singapore (including Chor Guek Chua, Dr Rajeswari Moothathamby, and Job Loei), and all study participants for support of the program.
Prior Presentation: Aspects of this study have been presented in abstract form at the 50th European Renal Association−European Dialysis
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Complete author and article information provided before references.
Authors’ Full Names and Academic Degrees: Konstadina Griva, PhD, Mooppil Nandakumar, MRCP (UK), Jo-an H. Ng, BSocSci (Hon), Kevin F.Y. Lam, BSocSci (Hon), Hayley McBain, PhD, and Stanton P. Newman, DPhil.
Authors’ Contributions: Research idea and study design: KG, SPN, HMcB; data acquisition: JHN, MN; data analysis/interpretation: KG, HMcB; statistical analysis: KG, KFYL; supervision or mentorship: KG. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved.
Support: The study was funded by the NKF Singapore Research Fund (NKFRC2008/07/24) and Ministry of Education-NUS Academic Research Fund (FY2007-FRC5-006). Dr Griva received research funding from NKF Singapore. The funding sources had no role in the study design or intervention, recruitment of patients, data collection, analysis, or interpretation of the results, writing of the manuscript, or decision to submit the manuscript for publication.
Financial Disclosures: The authors declare that they have no other relevant financial interests.