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Abstract: SA-PO493

Overcoming Recruitment Obstacles in a Trial Examining Intradialytic Plantar Electrical Nerve Stimulation in Diabetic Hemodialysis Patients

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Hamad, Abdullah Ibrahim, Hamad Medical Corporation, Doha, Qatar
  • Najafi, Bijan, Baylor College of Medicine, Houston, Texas, United States
  • Lee, Myeounggon, Baylor College of Medicine, Houston, Texas, United States
  • Ibrahim, Rania Abdelaziz, Hamad Medical Corporation, Doha, Qatar
  • Mathew, Mincy, Hamad Medical Corporation, Doha, Qatar
  • Ateya, Heba Mohamed, Hamad Medical Corporation, Doha, Qatar
  • Zitouni, Yoldez, Hamad Medical Corporation, Doha, Qatar
  • Al-Ali, Fadwa S., Hamad Medical Corporation, Doha, Qatar
Background

Recruitment of patients on hemodialysis (HD) into a clinical trial is challenging (HD schedule, post-HD fatigue, polypharmacy, and physical and mental conditions). COVID-19 pandemic added an extra challenge
(manpower, funding, and physical distance). We present challenges we faced in screening, recruiting, and retaining patients in our study of intradialytic plantar electrical nerve stimulation (iPENS).

Methods

Our study design is a double-blind, randomized controlled trial. We used iPENS to improve gait, balance and mobility (assessed using wearable sensors) among diabetic patients undergoing HD. Patients received either 1-hour active iPENS or non-functional iPENS during every HD for 12 weeks. Our original target was to recruit 100 patients over 4 year study period.

Results

We screened 540 HD patients in 2018-23. 410 (76%) patients were excluded (mostly non-diabetic and non-ambulatory patients. 130 (24%) patients met the inclusion criteria, but 19 (14.6%) refused to participate (not interested in any extra tasks during HD). 111 patients consented, but 18 (16.2%) of patients dropped (mostly due to COVID-19 interruptions). In the end, 92 patients (17% of the total screened patients) completed the study. Our study faced 11 months interruption related to COVID-19 pandemic. No patients discontinued the study because of extra burden or side effects. Most patients reported positive feedback and experience, with many requesting to continue the intervention beyond the study duration.

Conclusion

Our study was successful in recruiting its target despite its complexity and the challenges it faced. Creating an innovative study design that suits patients' schedules was essential to our success.

Funding

  • Government Support – Non-U.S.