Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study

Background: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants’ demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. Methods: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants’ wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. Results: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), “satisfaction with my wear of orthopaedic footwear” was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. Conclusions: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people’s wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. Trial registration: Netherlands Trial Register NL7710. Registered: 6 May 2019

Using motivational interviewing combined with digital shoe-fitting to improve adherence to wearing orthopedic shoes in people with diabetes at risk of foot ulceration: study protocol for a clusterrandomized controlled trial

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

Using motivational interviewing combined with digital shoe-fitting to improve adherence to wearing orthopedic shoes in people with diabetes at risk of foot ulceration: study protocol for a cluster-randomized controlled trial

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

Attitudes and experiences towards the application of motivational interviewing by podiatrists working with people with diabetes at high-risk of developing foot ulcers: a mixed-methods study

Background: Podiatrists are key professionals in promoting adequate foot self-care for people with diabetes at high-risk of developing foot ulcers. However, merely informing patients about the advantages of foot self-care is insufficient to realise behavioural change. Motivational interviewing (MI) is a promising person-centred communication style that could help to create a working alliance between healthcare providers and patient to improve foot self-care. This study aims to observe and analyse the application of MI in consultations carried out by MI-trained and non-MI-trained podiatrists with their patients, and explore podiatrists’ attitudes and experiences towards MI. Methods: Eighteen podiatrists (median age: 28.5 years, 10 female and 8 male) followed a three-day basic training in MI and 4 podiatrists (median age: 38.5 years, 4 female) were not trained in MI. To observe and rate the MI-fidelity in daily clinical practice, audio recordings from the MI-trained and non-MI-trained podiatrists were scored with the Motivational Interviewing Treatment Integrity code. Individual, semi-structed, in-depth interviews were conducted with the MI-trained podiatrists to explore their attitudes towards and experiences with MI. These data sources were triangulated to describe the effect of training podiatrists in MI for their clinical practice. Results: The MI-trained podiatrists scored significantly higher than the non-MI-trained podiatrists on two of four global MI-related communication skills (empathy, p = 0.008 and change talk, p = 0.008), on one of five core MI-adherent behaviours (affirmation, p = 0.041) and on one of the other behaviour counts (simple reflections, p = 0.008). The podiatrists mainly reported their attitudes and experiences regarding partnership and cultivating change talk, during the interviews. In addition, they also mentioned facilitators and barriers to using MI and indicated whether they experienced MI as having added value. Conclusions: The MI-trained podiatrists used the principles of MI at a solid beginner proficiency level in their clinical practice in comparison to the non-MI-trained podiatrists, who did not reach this level. This achievement is in accordance with the basic MI-training they received. This multi-method study reveals that podiatrists can be effectively trained in applying MI in daily clinical practice. Trial registration: Netherlands Trial Register NL7710. Registered: 6 May 2019

Attitudes and experiences towards the application of motivational interviewing by podiatrists working with people with diabetes at high‑risk of developing foot ulcers: a mixed‑methods study

Background Podiatrists are key professionals in promoting adequate foot self-care for people with diabetes at high-risk of developing foot ulcers. However, merely informing patients about the advantages of foot self-care is insufficient to realise behavioural change. Motivational interviewing (MI) is a promising person-centred communication style that could help to create a working alliance between healthcare providers and patient to improve foot self-care. This study aims to observe and analyse the application of MI in consultations carried out by MI-trained and non-MI-trained podiatrists with their patients, and explore podiatrists’ attitudes and experiences towards MI. Methods Eighteen podiatrists (median age: 28.5 years, 10 female and 8 male) followed a three-day basic training in MI and 4 podiatrists (median age: 38.5 years, 4 female) were not trained in MI. To observe and rate the MI-fidelity in daily clinical practice, audio recordings from the MI-trained and non-MI-trained podiatrists were scored with the Motivational Interviewing Treatment Integrity code. Individual, semi-structed, in-depth interviews were conducted with the MI-trained podiatrists to explore their attitudes towards and experiences with MI. These data sources were triangulated to describe the effect of training podiatrists in MI for their clinical practice. Results The MI-trained podiatrists scored significantly higher than the non-MI-trained podiatrists on two of four global MI-related communication skills (empathy, p = 0.008 and change talk, p = 0.008), on one of five core MI-adherent behaviours (affirmation, p = 0.041) and on one of the other behaviour counts (simple reflections, p = 0.008). The podiatrists mainly reported their attitudes and experiences regarding partnership and cultivating change talk, during the interviews. In addition, they also mentioned facilitators and barriers to using MI and indicated whether they experienced MI as having added value. Conclusions The MI-trained podiatrists used the principles of MI at a solid beginner proficiency level in their clinical practice in comparison to the non-MI-trained podiatrists, who did not reach this level. This achievement is in accordance with the basic MI-training they received. This multi-method study reveals that podiatrists can be effectively trained in applying MI in daily clinical practice. Trial registration Netherlands Trial Register NL7710. Registered: 6 May 2019