Title
Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial
Date Issued
01 January 2020
Access level
open access
Resource Type
journal article
Publisher(s)
F1000 Research Ltd
Taylor & Francis
Abstract
Background: Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). Methods: We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Conclusions: In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015)
Volume
5
Language
English
OCDE Knowledge area
Endocrinología, Metabolismo (incluyendo diabetes, hormonas)
Scopus EID
2-s2.0-85091121420
Source
Wellcome Open Research
ISSN of the container
2398-502X
Sponsor(s)
AB-O was funded by the Wellcome Trust as a Research Training Fellow in Public Health and Tropical Medicine [103994]. This project is funded by the Fogarty International Center, National Institutes of Health [R21TW009982], under the Global Alliance for Chronic Diseases (GACD) Diabetes Program. JJM currently receives or has received during the planning and conduction of this study further support from the Alliance for Health Policy and Systems Research [HQHSR1206660], Consejo Nacional de Ciencia y Tecnología (CONCYTEC), DFID/MRC/Wellcome Global Health Trials [MR/M007405/1], Grand Challenges Canada [0335-04], the International Development Research Centre Canada [106887-001], the Inter-American Institute for Global Change Research [IAI CRN3036], the Medical Research Council [MR/P008984/1, MR/P024408/1, MR/P02386X/1], the National Cancer Institute [1P20CA217231], the National Heart, Lung and Blood Institute [5U01HL114180, HHSN268200900028C-3-0-1], the National Institute of Mental Health [1U19MH098780], the Swiss National Science Foundation [40P740-160366], Universidad Peruana Cayetano Heredia, and the Wellcome Trust [GR074833MA, WT093541AIA, 074833, 205177]. Our acknowledgments go to the fieldworkers Carmen Cisneros, Yvonne Huaylinos, Edith Rojas and Angela Roncal for their work and support in the implementation of the intervention. Also, we would like to thanks to the health professionals including physicians, nurses and technicians from the Endocrinology Services of the Hospital Cayetano Heredia and Hospital Nacional Arzobispo Loayza. This study would not have been possible without the involvement of the participants, and we appreciate their time and commitment to the study. We are also grateful to Sol Abarca, Jorge Chachaima Mar, Gianpier Rojas and Bridgette Zarzosa Mezzich for their collaboration in data quality control and the revision of the participant's logbook. Finally, we would like to thank to Jill Portocarrero for her support in the process evaluation of the study, Miguel Moscoso Porras for his initial support in the design of the messaging system and to the engineers Jorge Estrada and Oscar Giraldo for the development and monitoring of the messaging system. Grant information: AB-O was funded by the Wellcome Trust as a Research Training Fellow in Public Health and Tropical Medicine [103994]. This project is funded by the Fogarty International Center, National Institutes of Health [R21TW009982], under the Global Alliance for Chronic Diseases (GACD) Diabetes Program. JJM currently receives or has received during the planning and conduction of this study further support from the Alliance for Health Policy and Systems Research [HQHSR1206660], Consejo Nacional de Ciencia y Tecnología (CONCYTEC), DFID/MRC/Wellcome Global Health Trials [MR/M007405/1], Grand Challenges Canada [0335-04], the International Development Research Centre Canada [106887-001], the Inter-American Institute for Global Change Research [IAI CRN3036], the Medical Research Council [MR/P008984/1, MR/P024408/1, MR/P02386X/1], the National Cancer Institute [1P20CA217231], the National Heart, Lung and Blood Institute [5U01HL114180, HHSN268200900028C-3-0-1], the National Institute of Mental Health [1U19MH098780], the Swiss National Science Foundation [40P740-160366], Universidad Peruana Cayetano Heredia, and the Wellcome Trust [GR074833MA, WT093541AIA, 074833, 205177].
Sources of information: Directorio de Producción Científica Scopus