Dataset Information

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

ABSTRACT:

Background

Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial.

Objective

The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care.

Methods

The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4-percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention.

Results

The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024.

Conclusions

This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes.

Trial registration

ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379.

International registered report identifier (irrid)

DERR1-10.2196/32918.

SUBMITTER: Farmer A

PROVIDER: S-EPMC8902673 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

Farmer Andrew A Jones Louise L Newhouse Nikki N Kenning Cassandra C Williams Nicola N Chi Yuan Y Bartlett Y Kiera YK Plumpton Catrin C McSharry Jenny J Cholerton Rachel R Holmes Emily E Robinson Stephanie S Allen Julie J Gudgin Bernard B Velardo Carmelo C Rutter Heather H Horne Rob R Tarassenko Lionel L Williams Veronika V Locock Louise L Rea Rustam R Yu Ly-Mee LM Hughes Dyfrig D Bower Peter P French David D

JMIR research protocols 20220221 2

<h4>Background</h4>Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identifi ...[more]

PMID: 35188478

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Project description:IntroductionType 2 diabetes is common, affecting over 400 million people worldwide. Risk of serious complications can be reduced through use of effective treatments and active self-management. However, people are often concerned about starting new medicines and face difficulties in taking them regularly. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. We have developed messages aiming to support patients' self-management of type 2 diabetes in the use of medications and other aspects of self-management, underpinned by theory and evidence. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the intervention, compared with usual care.Methods and analysisThe feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England. Consenting participants will be randomised to receive short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6 months. The aims are to test recruitment methods, retention to the study, the feasibility of data collection and the mobile phone and web-based processes of a proposed definitive trial and to refine the text messaging intervention. The primary outcome is the rate of recruitment to randomisation of participants to the trial. Data, including patient reported measures, will be collected online at baseline and the end of the 6-month follow-up period. With 200 participants (100 in each group), this trial is powered to estimate 80% follow-up within 95% CIs of 73.8% to 85.3%. The analysis will follow a prespecified plan.Ethics and disseminationEthics approval was obtained from the West of Scotland Research Ethics Committee 05. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: www.summit-d.org (SuMMiT-D (SUpport through Mobile Messaging and digital health Technology for Diabetes)).Trial registration numberISRCTN13404264.

Project description:BackgroundThe purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection.MethodsA multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months.ResultsThe trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants.ConclusionThe feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable.Trial registrationISCTRN ISRCTN13404264. Registered on 10 October 2018.

Project description:BackgroundIntegrated care can generate health and social care efficiencies through the defragmentation of care and adoption of patient-centered preventive models. eHealth can be a key enabling technology for integrated care.ObjectiveThe aim of this study was to assess the effectiveness and cost-effectiveness of the implementation of a mobile health (mHealth)-enabled integrated care model for complex chronic patients.MethodsAs part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, two-arm, parallel implementation trial was held in a rural region of Catalonia, Spain. During 3 months, elderly patients with chronic obstructive pulmonary disease or heart failure and their carers experienced the combined benefits of the CONNECARE organizational integrated care model and the eHealth platform supporting it, consisting of a patient self-management app, a set of integrated sensors, and a web-based platform connecting professionals from different settings, or usual care. We assessed changes in health status with the 12-Item Short-Form Survey (SF-12), unplanned visits and admissions during a 6-month follow up, and the incremental cost-effectiveness ratio (ICER).ResultsA total of 48 patients were included in the integrated care arm and 28 patients receiving usual care were included in the control arm (mean age 82 years, SD 7 years; mean Charlson index 7, SD 2). Integrated care patients showed a significant increase in the SF-12 physical domain with a mean change of +3.7 (SD 8.4) (P=.004) and total SF-12 score with a mean change of +5.8 (SD 12.8) (P=.003); however, the differences in differences between groups were not statistically significant. Integrated care patients had 57% less unplanned visits (P=.004) and 50% less hospital admissions related to their main chronic diseases (P=.32). The integrated care program generated savings in different cost scenarios and the ICER demonstrated the cost-effectiveness of the program.ConclusionsThe implementation of a patient-centered mHealth-enabled integrated care model empowering the patient, and connecting primary, hospital, and social care professionals reduced unplanned contacts with the health system and health costs, and was cost-effective. These findings support the notion of system-wide cross-organizational care pathways supported by mHealth as a successful way to implement integrated care.

Project description:BackgroundThe amount of information needed by doctors has exploded. The nature of knowledge (explicit and tacit) and processes of knowledge acquisition and participation are complex. Aiming to assist workplace learning, Wales Deanery funded "iDoc", a project offering trainee doctors a Smartphone library of medical textbooks.MethodsData on trainee doctors' (Foundation Year 2) workplace information seeking practice was collected by questionnaire in 2011 (n = 260). iDoc baseline questionnaires (n = 193) collected data on Smartphone usage alongside other workplace information sources. Case reports (n = 117) detail specific instances of Smartphone use.ResultsMost frequently (daily) used information sources in the workplace: senior medical staff (80% F2 survey; 79% iDoc baseline); peers (70%; 58%); and other medical/nursing team staff (53% both datasets). Smartphones were used more frequently by males (p < 0.01). Foundation Year 1 (newly qualified) was judged the most useful time to have a Smartphone library because of increased responsibility and lack of knowledge/experience.Preferred information source varied by question type: hard copy texts for information-based questions; varied resources for skills queries; and seniors for more complex problems. Case reports showed mobile technology used for simple (information-based), complex (problem-based) clinical questions and clinical procedures (skills-based scenarios). From thematic analysis, the Smartphone library assisted: teaching and learning from observation; transition from medical student to new doctor; trainee doctors' discussions with seniors; independent practice; patient care; and this 'just-in-time' access to reliable information supported confident and efficient decision-making.ConclusionA variety of information sources are used regularly in the workplace. Colleagues are used daily but seniors are not always available. During transitions, constant access to the electronic library was valued. It helped prepare trainee doctors for discussions with their seniors, assisting the interchange between explicit and tacit knowledge.By supporting accurate prescribing and treatment planning, the electronic library contributed to enhanced patient care. Trainees were more rapidly able to medicate patients to reduce pain and more quickly call for specific assessments. However, clinical decision-making often requires dialogue: what Smartphone technology can do is augment, not replace, discussion with their colleagues in the community of practice.

Project description:BackgroundA growing number of mobile health (mHealth) technology-based apps are being developed for personal lifestyle and medical health care support, of which several apps are related to pregnancy. Evidence on usability and effectiveness is limited but crucial for successful implementation.ObjectiveThis study aimed to evaluate the usability, that is, feasibility and acceptability, as well as effectiveness of mHealth lifestyle and medical apps to support health care during pregnancy in high-income countries. Feasibility was defined as the actual use, interest, intention, and continued use; perceived suitability; and ability of users to carry out the activities of the app. Acceptability was assessed by user satisfaction, appreciation, and the recommendation of the app to others.MethodsWe performed a systematic review searching the following electronic databases for studies on mHealth technology-based apps in maternal health care in developed countries: EMBASE, MEDLINE Epub (Ovid), Cochrane Library, Web of Science, and Google Scholar. All included studies were scored on quality, using the ErasmusAGE Quality Score or the consolidated criteria for reporting qualitative research. Main outcome measures were usability and effectiveness of mHealth lifestyle and medical health care support apps related to pregnancy. All studies were screened by 2 reviewers individually, and the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement were followed.ResultsOur search identified 4204 titles and abstracts, of which 2487 original studies remained after removing duplicates. We performed full-text screening of 217 studies, of which 29 were included in our study. In total, 19 out of 29 studies reported on mHealth apps to adopt healthy lifestyles and 10 out of 29 studies to support medical care. The lifestyle apps evaluated in 19 studies reported on usability and effectiveness: 10 studies reported positive on acceptability, and 14 studies reported on feasibility with positive results except one study. In total, 4 out of 19 studies evaluating effectiveness showed significant results on weight gain restriction during pregnancy, intake of vegetables and fruits, and smoking cessation. The 10 studies on medical mHealth apps involved asthma care, diabetic treatment, and encouraging vaccination. Only one study on diabetic treatment reported on acceptability with a positive user satisfaction. In total, 9 out of 10 studies reported on effectiveness. Moreover, the power of most studies was inadequate to show significant effects.ConclusionsMost studies on mHealth apps to support lifestyle and medical care for high-income countries reveal the usability of these apps to reduce gestational weight gain, increase intakes of vegetables and fruit, to quit smoking cessation, and to support health care for prevention of asthma and infections during pregnancy. In general, the evidence on effectiveness of these apps is limited and needs further investigation before implementation in medical health care.

Project description:BACKGROUND:Mobile health (mHealth) apps have the potential to support patients' medication use and are therefore increasingly used. Apps with broad functionality are suggested to be more effective; however, not much is known about the actual use of different functionalities and the effective engagement. OBJECTIVE:The aim of this study was to explore the use and the effective engagement of adolescents (aged 12 to 18 years) with the Adolescent Adherence Patient Tool (ADAPT). METHODS:The ADAPT intervention consisted of an app for patients, which was connected to a management system for their pharmacist. The aim of the ADAPT intervention was to improve medication adherence and, therefore, the app contained multiple functionalities: questionnaires to monitor symptoms and adherence, medication reminders, short movies, pharmacist chat, and peer chat. For this study, data of the ADAPT study and a cluster randomized controlled trial were used. Adolescents with asthma had 6 months' access to the ADAPT intervention, and all app usage was securely registered in a log file. RESULTS:In total, 86 adolescents (mean age 15.0, SD 2.0 years) used the ADAPT app 17 times (range 1-113) per person. Females used the app more often than males (P=.01) and for a longer period of time (P=.03). On average, 3 different functionalities were used, and 13% of the adolescents used all functionalities of the app. The questionnaires to monitor symptoms and adherence were used by most adolescents. The total app use did not affect adherence; however, activity in the pharmacist chat positively affected medication adherence (P=.03), in particular, if patients sent messages to their pharmacist (P=.01). CONCLUSIONS:mHealth apps for adolescents with asthma should contain different functionalities to serve the diverging needs and preferences of individual patients. Suggested key functionalities to promote use and effectiveness in adolescents with asthma are questionnaires to monitor symptoms and a health care provider chat.

Dataset Information

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

Similar Datasets

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