Dataset Information

Implementation of a novel mHealth application for the management of people with diabetes and recently healed foot ulceration: A feasibility study.

ABSTRACT:

Background

Diabetic foot ulcers (DFUs) cause significant morbidity and mortality. Faster referral to specialist clinics is associated with a reduced risk of severe DFUs. The INTELLIN^® diabetes management platform is a novel mHealth application for the management of recently healed DFUs and other complications, promoting engagement and expediting self-referral.

Methods

To determine the acceptability, suitability, and usability of the INTELLIN^® platform, time until reulceration, site, ischemia, neuropathy, bacterial infection, and depth (SINBAD) score and incidence of self-referral for recurrence were assessed in patients from the Salford Royal NHS Foundation Trust. Patients and clinic staff also assessed platform usability. A Markov cost-utility model was used for the health economics and outcomes research analysis.

Results

197 patients were assessed for eligibility and 15 entered the full analysis set (FAS). Through Week 52, 8/15 patients experienced recurrence, with a mean SINBAD score of 2.1 and mean duration of 2.6 days. Mean time to recurrence was 273.0 days (95% confidence interval 74.0, 484.0). No patients self-referred. Initial qualitative data showed high platform usability. The INTELLIN^® platform only required a relative reduction in recurrence of 5% versus standard of care (SoC) for an incremental cost effectiveness ratio of £20,000 per quality-adjusted life-year, suggesting potential for significant cost savings upon wider adoption. The barriers to enrollment encountered demonstrate the impact of socioeconomics on mHealth.

Conclusions

These results suggest that the INTELLIN^® platform is required to provide only a small reduction in recurrence compared to SoC to be a cost-effective strategy for prevention of recurrent DFUs.

SUBMITTER: Haycocks S

PROVIDER: S-EPMC9732796 | biostudies-literature | 2022 Jan-Dec

REPOSITORIES: biostudies-literature

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Publications

Implementation of a novel mHealth application for the management of people with diabetes and recently healed foot ulceration: A feasibility study.

Haycocks Samantha S Cameron Rory R Edge Mark M Budd Jayne J Chadwick Paul P

Digital health 20220101

<h4>Background</h4>Diabetic foot ulcers (DFUs) cause significant morbidity and mortality. Faster referral to specialist clinics is associated with a reduced risk of severe DFUs. The INTELLIN<sup>®</sup> diabetes management platform is a novel mHealth application for the management of recently healed DFUs and other complications, promoting engagement and expediting self-referral.<h4>Methods</h4>To determine the acceptability, suitability, and usability of the INTELLIN<sup>®</sup> platform, time u ...[more]

PMID: 36506489

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Project description:BackgroundDiabetic foot ulcers (DFUs) cause significant morbidity affecting 19% to 34% of people living with diabetes mellitus. DFUs not only impair quality of life but may also result in limb loss and mortality. Patient education has been advocated to raise awareness of proper foot self-care and the necessity of seeking assistance when a foot wound occurs. Modern technologies, including mobile health (mHealth) interventions such as health apps, bring the potential for more cost-effective and scalable interventions.ObjectiveThis study aims to examine the feasibility and usability of a newly developed mHealth app called Well Feet, which is a diabetes and foot care education app for individuals at risk of developing DFU.MethodsWell Feet was developed using an evidence-based and expert panel cocreation approach to deliver educational content available in 3 languages (ie, English, Chinese, and Malay) via animation videos and a range of additional features, including adaptive learning. A nonrandomized, single-arm feasibility study using a mixed methods approach with a series of validated questionnaires and focus group discussions will be conducted. In total, 40 patients and carers will be recruited from a tertiary hospital diabetes clinic to receive a 1-month mHealth intervention. The primary outcomes are the usability of the app and a qualitative perspective on user experience. Secondary outcomes include changes in foot care knowledge, self-management behaviors, and quality of life.ResultsPatient recruitment began in July 2023, and the intervention and data collection will be completed by the end of September 2023. This study has been approved by National Healthcare Group Domain Specific Review Board (2022/00614) on February 10, 2023. The expected results will be published in spring 2024.ConclusionsThrough this feasibility study, the Well Feet DFU education app will undergo a comprehensive quantitative and qualitative evaluation of its usability and acceptance for future improvement in its design. With local contextualization, cultural adaptation, and its multilingual functionality, the app addresses a critical aspect of DFU health education and self-management in a multiethnic population. Findings from this study will refine and enhance the features of the app based on user feedback and shape the procedural framework for a subsequent randomized controlled trial to assess the effectiveness of Well Feet.Trial registrationClinicalTrials.gov NCT05564728; https://clinicaltrials.gov/study/NCT05564728.International registered report identifier (irrid)DERR1-10.2196/52036.

Project description:BackgroundDiabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period.Methods/designThis is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru.Interventionsparticipants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care.Outcomesthe primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study.DiscussionThis study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.Trial registrationThis study is registered in ClinicalTrials.gov: Identifier NCT02373592 .

Project description:BackgroundDay surgery is being increasingly implemented across Europe, driven in part by capacity problems. Patients recovering at home could benefit from tools tailored to their new care setting to effectively manage their convalescence. The mHealth application ikHerstel is one such tool, but although it administers its functions in the home, its implementation hinges on health care professionals within the hospital.ObjectiveWe conducted a feasibility study of an additional patient-oriented implementation strategy for ikHerstel. This strategy aimed to empower patients to access and use ikHerstel independently, in contrast to implementation as usual, which hinges on the health care professional acting as gatekeeper. Our research question was "How well are patients able to use ikHerstel independently of their health care professional?"MethodsWe investigated the implementation strategy in terms of its recruitment, reach, dose delivered, dose received, and fidelity. Patients with a recent or prospective elective surgery were recruited using a wide array of materials to simulate patient-oriented dissemination of ikHerstel. Data were collected through web-based surveys. Descriptive analysis and open coding were used to analyze the data.ResultsRecruitment yielded 213 registrations, with 55 patients ultimately included in the study. The sample was characterized by patients undergoing abdominal surgery, with high literacy and above average digital health literacy, and included an overrepresentation of women (48/55, 87%). The implementation strategy had a reach of 81% (63/78), with 87% (55/67) of patients creating a recovery plan. Patients were satisfied with their independent use of ikHerstel, rating it an average 7.0 (SD 1.9) of 10, and 54% (29/54) of patients explicitly reported no difficulties in using it. A major concern of the implementation strategy was conflicts in recommendations between ikHerstel and the health care professionals, as well as the resulting feelings of insecurity experienced by patients.ConclusionsIn this small feasibility study, most patients were satisfied with the patient-oriented implementation strategy. However, the lack of involvement of health care professionals due to the strategy contributed to patient concerns regarding conflicting recommendations between ikHerstel and health care professionals.

Project description:AimsElevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers.MethodsPublished articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310).ResultsEight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, p<0.001; and 0.762, 95% CI 0.303-1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181- 0.753, p = 0.001). Statistical heterogeneity between studies was moderate.ConclusionsPlantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.

Project description:PurposeThis aim of this study was to evaluate the clinical efficacy of a self-managed cooling intervention in individuals with recently healed venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) on pain reduction and physical activity improvement.DesignA 6-month longitudinal randomized controlled trial.Subjects and settingThe sample comprised 140 individuals with previously healed VLU and DFU who received care in 3 outpatient wound centers in the Southeastern region of the United States. Participants were randomized to the MUSTCOOL or a placebo cooling patch intervention.MethodsThe cooling and placebo interventions comprised cooling or cotton-filled patch application to recently healed skin for 30 minutes, 3 times weekly plus standard of care including compression and leg elevation (participants with VLU) or therapeutic footwear and hygiene (participants with DFU) over a 6-month period. Pain severity and intensity were measured with the Brief Pain Inventory and physical activity with the International Physical Activity Questionnaire, which assessed metabolic equivalent of tasks (METs) in minutes per week. Minutes in walking time per week were assessed with an accelerometer. Data were descriptively analyzed for difference changes in scores from baseline to 6 months post-intervention.ResultsData were analyzed for 81 participants randomized to cooling and placebo groups (VLUs, n = 26/29) and DFU (n = 12/16). Slight reductions in VLU pain severity (-0.5, -0.2) and interference (-0.4, -0.5) and minimal reductions in DFU pain severity (0, -0.1) and interference (0.4/0.1) were achieved. However, pain scores were low to moderate at baseline (mean 4, 0-10 with 10 worst pain possible) in both groups. For physical activity, the MET values showed low physical activity in both groups at baseline with slight improvements noted in VLU cooling and placebo groups (73/799) and DFU (1921/225), respectively. Walking time for the VLU groups improved by 1420/2523 minutes; the DFU groups improved 135/157 minutes, respectively. Findings for outcomes were not statistically significant within or between groups.ConclusionsApplication of the cooling pack compared to placebo was minimally efficacious in reducing posthealing pain and improving function in this posthealed ulcer population. However for pain, scores were initially low; thus outcomes on pain, while lower, were marginal.Trial registrationThe study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156), https://clinicaltrials.gov/ct2/show/NCT02626156 .

Dataset Information

Implementation of a novel mHealth application for the management of people with diabetes and recently healed foot ulceration: A feasibility study.

Background

Methods

Results

Conclusions

Publications

Implementation of a novel mHealth application for the management of people with diabetes and recently healed foot ulceration: A feasibility study.

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