Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol

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 effe...

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Main Authors: Oluchi, Sampson Emilia, Abdul Manaf, Rosliza, Ismail, Suriani, Kadir Shahar, Hayati, Udeani, Theophilus Kachidelu, Uchegbu, Uchenna Nwachinemere
Format: Article
Language:English
Published: Universiti Putra Malaysia Press 2023
Online Access:http://psasir.upm.edu.my/id/eprint/108371/
http://psasir.upm.edu.my/id/eprint/108371/1/108371.pdf
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author Oluchi, Sampson Emilia
Abdul Manaf, Rosliza
Ismail, Suriani
Kadir Shahar, Hayati
Udeani, Theophilus Kachidelu
Uchegbu, Uchenna Nwachinemere
author_facet Oluchi, Sampson Emilia
Abdul Manaf, Rosliza
Ismail, Suriani
Kadir Shahar, Hayati
Udeani, Theophilus Kachidelu
Uchegbu, Uchenna Nwachinemere
author_sort Oluchi, Sampson Emilia
building UPM Institutional Repository
collection Online Access
description 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.
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spelling upm-1083712025-06-20T07:31:30Z http://psasir.upm.edu.my/id/eprint/108371/ Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol Oluchi, Sampson Emilia Abdul Manaf, Rosliza Ismail, Suriani Kadir Shahar, Hayati Udeani, Theophilus Kachidelu Uchegbu, Uchenna Nwachinemere 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. Universiti Putra Malaysia Press 2023 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/108371/1/108371.pdf Oluchi, Sampson Emilia and Abdul Manaf, Rosliza and Ismail, Suriani and Kadir Shahar, Hayati and Udeani, Theophilus Kachidelu and Uchegbu, Uchenna Nwachinemere (2023) Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol. Malaysian Journal of Medicine and Health Sciences, 19 (5). pp. 421-427. ISSN 1675-8544; eISSN: 2636-9346 https://medic.upm.edu.my/upload/dokumen/2023091816533347_MJMHS_0607.pdf 10.47836/mjmhs.19.5.48
spellingShingle Oluchi, Sampson Emilia
Abdul Manaf, Rosliza
Ismail, Suriani
Kadir Shahar, Hayati
Udeani, Theophilus Kachidelu
Uchegbu, Uchenna Nwachinemere
Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
title Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
title_full Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
title_fullStr Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
title_full_unstemmed Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
title_short Two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
title_sort two arm single-blind parallel randomized controlled trial effects of health education intervention on foot self-care behavior among diabetic patients: study protocol
url http://psasir.upm.edu.my/id/eprint/108371/
http://psasir.upm.edu.my/id/eprint/108371/
http://psasir.upm.edu.my/id/eprint/108371/
http://psasir.upm.edu.my/id/eprint/108371/1/108371.pdf