Two Arm Single-blind Parallel Randomized Controlled Trial Effects of Health Education Intervention on Foot Self-care Behavior Among Diabetic Patients: Study Protocol
https://doi.org/10.47836/mjmhs.19.5.48
- Author:
Sampson Emilia Oluchi
1
;
Rosliza Abdul Manaf
1
;
Suriani Ismail
1
;
Hayati Kadir Shahar
1
;
Theophilus Kachidelu Udeani
2
,
3
;
Uchenna Nwachinemere Uchegbu
4
Author Information
1. Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia
2. Department of Medical Laboratory Sciences, Faculty of Health Sciences &
3. Technology College of Medicine, University of Nigeria Enugu Campus, Enugu 410001, Nigeria
4. Department of Medical Laboratory Science, Imo State University (IMSU) or Federal Medical Centre Owerri, 460108 Owerri, Imo, Nigeria
- Publication Type:Other Types
- Keywords:
Diabetes, Foot ulcer, Foot self-care, Health education
- From:Malaysian Journal of Medicine and Health Sciences
2023;19(No.5):421-427
- CountryMalaysia
- Language:English
-
Abstract:
Introduction: Diabetes is a chronic illness and it has a significant impact on health. Behavioral interventions theory
could improve self-care practices of the foot among patients with diabetic. Behavioral interventions could prevent
the risk of foot problems. This trial aims at determining the effect of patient education intervention on foot self-care
behavior and clinical outcomes among diabetes patients. Methods: The study is a two-arm single-blinded randomized controlled trial which will be conducted in the Federal Medical Centre (FMC) Owerri, Imo state, Nigeria involving 160 diabetic patients. A central computer-generated randomization list will be generated. Sequentially numbered
sealed opaque envelopes will be used to determine concealment. The sample size is 160; therefore 80 participants
will receive three sessions of patient education in addition to usual care (intervention group) for three and six months
while another 80 participants (control group) will receive only usual care and will receive health education after
the study is completed. The outcome of the intervention effectiveness is measured by modified version of Diabetes
foot Self-Care Behavior Scale (DFSBS). Discussion: Our hypothesis is that based on the Health Belief Model, patient
education intervention can improve foot self-care behavior in the intervention group. Data collection will be done
at baseline, and at three- and six-months post intervention. Trial Registration: The Clinical Trials Registry- India
(CTRI), Reference no CTRI/2021/06/034311.
- Full text:11.2023my1650.pdf
