scholarly journals Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility): a randomised feasibility trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033504
Author(s):  
Andrew Farmer ◽  
Julie Allen ◽  
Kiera Bartlett ◽  
Peter Bower ◽  
Yuan Chi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Mobile Phone ◽  
Health Technology ◽  
Text Messages ◽  
Feasibility Trial ◽  
Self Management ◽  
Link Type ◽  
Patient Reported

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.

scholarly journals EatSmart, a Web-Based and Mobile Healthy Eating Intervention for Disadvantaged People With Type 2 Diabetes: Protocol for a Pilot Mixed Methods Intervention Study (Preprint)

2020 ◽  
Author(s):  
Nazgol Karimi ◽  
David Crawford ◽  
Rachelle Opie ◽  
Ralph Maddison ◽  
Stella O’Connell ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Mixed Methods ◽  
Behavior Change ◽  
Healthy Eating ◽  
Text Messages ◽  
Self Management ◽  
Web Based ◽  
Disadvantaged People

BACKGROUND People of low socioeconomic position (SEP) are disproportionately affected by type 2 diabetes (T2D), partly due to unhealthy eating patterns that contribute to inadequate disease self-management and prognosis. Digital technologies have the potential to provide a suitable medium to facilitate diabetes education, support self-management, and address some of the barriers to healthy eating, such as lack of nutritional knowledge or shopping or cooking skills, in this target group. OBJECTIVE This study aims to test the feasibility, appeal, and potential effectiveness of EatSmart, a 12-week, evidence-based, theoretically grounded, fully automated web-based and mobile-delivered healthy eating behavior change program to help disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management. METHODS EatSmart is a mixed methods (quantitative and qualitative) pre-post design pilot study. Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years will be recruited. Participants will complete self-reported baseline assessments of their basic demographic and clinical data, dietary intake, dietary self-efficacy, and barriers to healthy eating. They will be provided with login access to the EatSmart web program, which includes six progressive skill-based modules covering healthy eating planning; smart food budgeting and shopping; time-saving meal strategies, healthy cooking methods, modifying recipes; and a final reinforcement and summary module. Over the 3-month intervention, participants will also receive 3 text messages weekly, encouraging them to review goals, continue to engage with different components of the EatSmart web program, and eat healthily. Participants will undertake follow-up assessments directly following the intervention 3 months post baseline and again after a 6-month postintervention follow-up period (9 months post baseline). Feasibility will be evaluated using the number of participants recruited and retained and objective indicators of engagement with the website. Program appeal and potential effects on primary and secondary outcomes will be assessed via the same surveys used at baseline, with additional questions asking about experience with and perceptions of the program. In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program’s appeal. RESULTS The EatSmart website has been developed, and all participants have viewed the modules as of May 2020. Results are expected to be submitted for publication in December 2020. CONCLUSIONS This study will provide data to address the currently limited evidence regarding whether disadvantaged populations with T2D may benefit from digitally delivered behavior change programs that facilitate eating healthily on a budget. CLINICALTRIAL Australian New Zealand Clinical Trials Registry, ACTRN12619001111167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001111167 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19488

scholarly journals Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

2021 ◽  
Vol 25 (77) ◽  
pp. 1-190
Author(s):  
Kamlesh Khunti ◽  
Simon Griffin ◽  
Alan Brennan ◽  
Helen Dallosso ◽  
Melanie Davies ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Health Technology ◽  
Accelerometer Data ◽  
Ambulatory Activity ◽  
Steps Per Day

Background Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives To investigate whether or not Walking Away from Diabetes (Walking Away) – a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes – leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting Primary care and the community. Participants Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval –290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval –282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration Current Controlled Trials ISRCTN83465245. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

scholarly journals Improving Glycaemic Control in Patients with Type 2 Diabetes Mellitus through A Peer Support Instant Messaging Service Intervention (Diabpeers): Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Elisabeth Höld ◽  
Johanna Grüblbauer ◽  
Martin Wiesholzer ◽  
Daniela Wewerka-Kreimel ◽  
Stefan Stieger ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Glycaemic Control ◽  
Standard Therapy ◽  
Instant Messaging ◽  
Self Management ◽  
Diabetes Therapy

Abstract Background: the context and purpose of the studyDiabetes mellitus is one of the four priority non-communicable diseases worldwide. It can lead to serious long-term complications and produces significant costs. Due to the chronicle character of the disease, it requires continuous medical treatment and good therapy adherence of those suffering. Therefore, diabetes self-management education (DSME) (and support DSMES) plays a significant role to increase patient’s self-management capacity and improve diabetes therapy. Research indicates that these outcomes might be difficult to maintain. Consequently, effective strategies to preserve the positive effects of DSMES are needed. Preliminary results show that peer support, which means support from a person who has experiential knowledge of a specific behaviour or stressor and similar characteristics as the target population, is associated with better outcomes in terms of HbA1c, cardiovascular disease risk factors or self-efficacy at lower cost compared to standard therapy. Peer-supported instant messaging services (IMS) approaches have significant potential for diabetes management because support can be provided easily and prompt, is inexpensive, and needs less effort to attend compared to standard therapy. The major objective of the study is to analyse the impact of a peer-supported IMS intervention in addition to a standard diabetes therapy on the glycaemic control of type 2 diabetic patients. Methods: how the study will be performedA total of 205 participants with type 2 diabetes mellitus will be included and randomly assigned to intervention or control group. Both groups will receive standard therapy, but the intervention group will participate in the peer-supported IMS intervention, additionally. The duration of the intervention will last for seven months, followed by a follow-up of seven months. Biochemical, behavioural and psychosocial parameters will be measured before, in the middle, and after the intervention as well as after the follow-up.Discussion: a brief summary and potential implicationsDiabetes mellitus type 2 and other non-communicable diseases put healthcare systems worldwide to the test. Peer-supported IMS interventions in addition to standard therapy might be part of new and cost-effective approaches to support patients independent from time and place.Trial registration: If your article reports the results of a health care intervention on human participants, it must be registered in an appropriate registry and the registration number and date of registration should be in stated in this section. If it was not registered prospectively (before enrollment of the first participant), you should include the words 'retrospectively registered'. See our editorial policies for more information on trial registration.ClinicalTrials.gov Identifier: NCT04797429Date of registration: 15 March 2021

scholarly journals Preferences for mHealth Technology and Text Messaging Communication in Patients With Type 2 Diabetes: Qualitative Interview Study (Preprint)

2020 ◽  
Author(s):  
Julie C Lauffenburger ◽  
Renee A Barlev ◽  
Ellen S Sears ◽  
Punam A Keller ◽  
Marie E McDonnell ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Health Care ◽  
Mobile Technology ◽  
Diabetes Care ◽  
Technology Use ◽  
Text Messages ◽  
Self Management ◽  
Care Providers ◽  
Mhealth Technology

BACKGROUND Individuals with diabetes need regular support to help them manage their diabetes on their own, ideally delivered via mechanisms that they already use, such as their mobile phones. One reason for the modest effectiveness of prior technology-based interventions may be that the patient perspective has been insufficiently incorporated. OBJECTIVE This study aims to understand patients’ preferences for mobile health (mHealth) technology and how that technology can be integrated into patients’ routines, especially with regard to medication use. METHODS We conducted semistructured qualitative individual interviews with patients with type 2 diabetes from an urban health care system to elicit and explore their perspectives on diabetes medication–taking behaviors, daily patterns of using mobile technology, use of mHealth technology for diabetes care, acceptability of text messages to support medication adherence, and preferred framing of information within text messages to support diabetes care. The interviews were digitally recorded and transcribed. The data were analyzed using codes developed by the study team to generate themes, with representative quotations selected as illustrations. RESULTS We conducted interviews with 20 participants, of whom 12 (60%) were female and 9 (45%) were White; in addition, the participants’ mean glycated hemoglobin A<sub>1c</sub> control was 7.8 (SD 1.1). Overall, 5 key themes were identified: patients try to incorporate <i>cues</i> into their routines to help them with consistent medication taking; many patients leverage some form of technology as a cue to support adherence to medication taking and diabetes self-management behaviors; patients value simplicity and integration of technology solutions used for diabetes care, managing medications, and communicating with health care providers; some patients express reluctance to rely on mobile technology for these diabetes care behaviors; and patients believe they prefer positively framed communication, but communication preferences are highly individualized. CONCLUSIONS The participants expressed some hesitation about using mobile technology in supporting diabetes self-management but have largely incorporated it or are open to incorporating it as a cue to make medication taking more automatic and less burdensome. When using technology to support diabetes self-management, participants exhibited individualized preferences, but overall, they preferred simple and positively framed communication. mHealth interventions may be improved by focusing on integrating them easily into daily routines and increasing the customization of content.

Losing weight following diagnosis of type 2 diabetes boosts chance of remission

BMJ ◽  
2020 ◽  
pp. l6775
Author(s):  
Rob Cook ◽  
Peter Davidson ◽  
Rosie Martin
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Cohort Study ◽  
National Health Service ◽  
Health Technology ◽  
Diabetes Diagnosis ◽  
Community Based ◽  
Link Type ◽  
Health Technology Assessment Programme

The study Dambha-Miller H, Day AJ, Strelitz J, et al. Behaviour change, weight loss and remission of Type 2 diabetes: a community-based prospective cohort study. Diabet Med 2019. doi: 10.1111/dme.14122 . This project was funded by the NIHR Health Technology Assessment Programme (project number 08/116/300) as well as the Wellcome Trust (grant number: G061895), the Epidemiology Unit programme (MC_UU_12015/4), and the National Health Service R&D support funding. To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000841/weight-loss-after-type-2-diabetes-diagnosis-boosts-chance-of-remission

scholarly journals Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Rebecca E. A. Walwyn ◽  
Amy M. Russell ◽  
Louise D. Bryant ◽  
Amanda J. Farrin ◽  
Alexandra M. Wright-Hughes ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Learning Disability ◽  
Study Protocol ◽  
Feasibility Trial ◽  
Self Management ◽  
Randomised Controlled

scholarly journals A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study

2016 ◽  
Vol 20 (64) ◽  
pp. 1-86 ◽  
Author(s):  
Rebecca K Simmons ◽  
Knut Borch-Johnsen ◽  
Torsten Lauritzen ◽  
Guy EHM Rutten ◽  
Annelli Sandbæk ◽  
...  
Keyword(s):  
Risk Factors ◽  
Patient Reported Outcomes ◽  
Cost Effective ◽  
Well Being ◽  
Health Technology ◽  
Patient Reported ◽  
All Cause Mortality

BackgroundIntensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain.ObjectiveTo quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes.DesignPragmatic, multicentre, cluster-randomised, parallel-group trial.SettingThree hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK.ParticipantsIndividuals aged 40–69 years with screen-detected diabetes.InterventionsScreening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol.Main outcome measuresThe primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3;©Isis Innovation Ltd 2010; seewww.dtu.ox.ac.uk/outcomesmodel(accessed 27 January 2016)].ResultsWe included 3055 (RC,n = 1377; IT,n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient.ConclusionsCompared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted.Trial registrationClinicalTrials.gov NCT00237549.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

scholarly journals A System Architecture Overview for the Support through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) Pilot and Randomised Controlled Feasibility Studies (Preprint)

2020 ◽  
Author(s):  
Yuan Chi ◽  
Carmelo Velardo ◽  
Julie Allen ◽  
Stephanie Robinson ◽  
Evgenia Riga ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Digital Health ◽  
Intervention Group ◽  
Feasibility Studies ◽  
Health Technology ◽  
Text Messages ◽  
Tailored Interventions ◽  
Wide Range ◽  
Randomised Controlled

BACKGROUND Diabetes is a highly prevalent long-term condition with high levels of morbidity and mortality [1]. People with diabetes commonly worry about their diabetes medicines, and do not always take them regularly as prescribed [2]. This can lead to poor diabetes controls. The Support through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines, to improve treatment adherence and health outcomes. OBJECTIVE This paper describes the overall architecture of a tailored intervention delivery system used in the pilot and randomised controlled feasibility studies of SuMMiT-D, and reports its performance. METHODS The SuMMiT-D system includes several platforms and resources to recruit participants and deliver messages as tailored interventions. Its core component is called the “clinical system”, and is responsible for interacting with the participants through receiving and sending SMS text messages from and to them. The personalisation and tailoring of brief messages for each participant is based on a list of built in commands that they can use. RESULTS For the pilot study, a total of 48 participants were recruited; they had a median age of 64 years, Q_1,〖 Q〗_3=[54.5,69]. For the feasibility study, a total of 209 participants were recruited and randomised to either the control or intervention group; they had a median age of 65 years, Q_1,Q_3=[56,71], with 41.15% being female. The participants used the SuMMiT-D system for up to 6 months (26 weeks), and had a wide range of different interactions with the SuMMiT-D system while being delivered tailored interventions. For both studies, we had a low withdrawal rates: only 4.2% and 5.3% for the pilot and feasibility studies, respectively. CONCLUSIONS A system was developed to successfully deliver brief messages as tailored health interventions to more than 250 people with type 2 diabetes via SMS text messages. Based on the low withdrawal rates and positive feedbacks received, it can suggest that the SuMMiT-D system is robust, user-friendly, useful, and positive for most participants. From the two studies, we found that online recruitment was more efficient than via postal mail; a regular SMS text reminder (e.g. every 4 weeks) can potentially increase the participants’ interactions with the system. CLINICALTRIAL iSRCTN13404264.

scholarly journals Mobile Phone-Based Self-Management Tools for Type 2 Diabetes: The Few Touch Application

2010 ◽  
Vol 4 (2) ◽  
pp. 328-336 ◽  
Author(s):  
E. Arsand ◽  
N. Tatara ◽  
G. ostengen ◽  
G. Hartvigsen
Keyword(s):  
Type 2 Diabetes ◽  
Mobile Phone ◽  
Self Management ◽  
Management Tools
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