TY - JOUR
T1 - Using motivational interviewing combined with digital shoe-fitting to improve adherence to wearing orthopedic shoes in people with diabetes at risk of foot ulceration
T2 - study protocol for a cluster-randomized controlled trial
AU - Jongebloed-Westra, M.
AU - Bode, C.
AU - van Netten, J. J.
AU - ten Klooster, P. M.
AU - Exterkate, S. H.
AU - Koffijberg, H.
AU - van Gemert-Pijnen, J. E. W. C.
N1 - Funding Information: This trial is funded by ZonMw (the Netherlands Organization for Health Research and Development, project no. 853001101). Both the funder and sponsor (University of Twente) had no influence in the study design; the collection, management, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication and had no ultimate authority over any of these activities. Funding Information: JvGP, CB, HK, and SE conceived and designed this trial. MJW, CB, HK, JvN, PtK, SE, and JvGP drafted or edited the trial protocols. MJW obtained ethical approval. PtK developed the statistical analysis plan. HK developed the plan for the cost-effectiveness analysis. MJW drafted the article. CB, HK, JvN, PtK, SE, and JvGP critically revised the article. The authors read and approved the final version of the manuscript. This trial is funded by ZonMw (the Netherlands Organization for Health Research and Development, project no. 853001101). Both the funder and sponsor (University of Twente) had no influence in the study design; the collection, management, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication and had no ultimate authority over any of these activities. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request after the publication of the results. Publisher Copyright: © 2021, The Author(s).
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Background: Diabetic foot ulcers have a high impact on mobility and daily functioning and lead to high treatment costs, for example, by hospitalization and amputation. To prevent (re)ulcerations, custom-made orthopedic shoes are considered essential. However, adherence to wearing the orthopedic shoes is low, and improving adherence was not successful in the past. We propose a novel care approach that combines motivational interviewing (MI) with a digital shoe-fitting procedure to improve adherence to orthopedic shoes. The aim of this trial is to assess the (cost-)effectiveness of this novel care approach compared to usual care (no MI and casting-based shoe-fitting) in promoting footwear adherence and ulcer prevention. Methods: The trial will include people with diabetes, with IWGDF Risk categories 1–3, who have been prescribed orthopedic shoes. Participants will be randomized at the level of the podiatrist to the novel care approach or usual care. The primary outcome is the proportion of participants who adhere to the use of their orthopedic shoes, that is, who take at least 80% of their total daily steps with orthopedic shoes. A temperature microsensor will be built into the participants’ orthopedic shoes to measure wearing time continuously over 12 months. In addition, daily activity will be measured periodically using log data with an activity monitor. Data from the temperature microsensor and activity monitor will be combined to calculate adherence. (Re-)experienced complications after receiving orthopedic shoes will be registered. Questionnaires and interviews will measure the experiences of participants regarding orthopedic shoes, experiences of podiatrists regarding motivational interviewing, care consumption, and quality of life. Differences in costs and quality of life will be determined in a cost-effectiveness analysis. Discussion: This trial will generate novel insights into the socio-economic and well-being impact and the clinical effectiveness of the novel care approach on adherence to wearing orthopedic shoes. Trial registration: Netherlands Trial Register NL7710. Registered on 6 May 2019.
AB - Background: Diabetic foot ulcers have a high impact on mobility and daily functioning and lead to high treatment costs, for example, by hospitalization and amputation. To prevent (re)ulcerations, custom-made orthopedic shoes are considered essential. However, adherence to wearing the orthopedic shoes is low, and improving adherence was not successful in the past. We propose a novel care approach that combines motivational interviewing (MI) with a digital shoe-fitting procedure to improve adherence to orthopedic shoes. The aim of this trial is to assess the (cost-)effectiveness of this novel care approach compared to usual care (no MI and casting-based shoe-fitting) in promoting footwear adherence and ulcer prevention. Methods: The trial will include people with diabetes, with IWGDF Risk categories 1–3, who have been prescribed orthopedic shoes. Participants will be randomized at the level of the podiatrist to the novel care approach or usual care. The primary outcome is the proportion of participants who adhere to the use of their orthopedic shoes, that is, who take at least 80% of their total daily steps with orthopedic shoes. A temperature microsensor will be built into the participants’ orthopedic shoes to measure wearing time continuously over 12 months. In addition, daily activity will be measured periodically using log data with an activity monitor. Data from the temperature microsensor and activity monitor will be combined to calculate adherence. (Re-)experienced complications after receiving orthopedic shoes will be registered. Questionnaires and interviews will measure the experiences of participants regarding orthopedic shoes, experiences of podiatrists regarding motivational interviewing, care consumption, and quality of life. Differences in costs and quality of life will be determined in a cost-effectiveness analysis. Discussion: This trial will generate novel insights into the socio-economic and well-being impact and the clinical effectiveness of the novel care approach on adherence to wearing orthopedic shoes. Trial registration: Netherlands Trial Register NL7710. Registered on 6 May 2019.
KW - Adherence
KW - Behavior
KW - Cost-effectiveness
KW - Diabetes mellitus
KW - Diabetic foot
KW - Motivational interviewing
KW - Orthopedic shoes
KW - Patient satisfaction
UR - http://www.scopus.com/inward/record.url?scp=85117960861&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-021-05680-0
DO - https://doi.org/10.1186/s13063-021-05680-0
M3 - Article
C2 - 34711263
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 750
ER -