Dataset Information

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care.

ABSTRACT:

Objective

To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.

Methods and design

Individually randomised two-arm controlled trial.

Setting

21 general practices in England.

Participants

Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.

Intervention and comparator

Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.

Outcomes and data collection

Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.

Analysis

The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.

Results

Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.

Conclusions

Access to HeLP-Diabetes improved glycaemic control over 12 months.

Trial registration number

ISRCTN02123133.

SUBMITTER: Murray E

PROVIDER: S-EPMC5623569 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care.

Murray Elizabeth E Sweeting Michael M Dack Charlotte C Pal Kingshuk K Modrow Kerstin K Hudda Mohammed M Li Jinshuo J Ross Jamie J Alkhaldi Ghadah G Barnard Maria M Farmer Andrew A Michie Susan S Yardley Lucy L May Carl C Parrott Steve S Stevenson Fiona F Knox Malcolm M Patterson David D

BMJ open 20170927 9

<h4>Objective</h4>To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.<h4>Methods and design</h4>Individually randomised two-arm controlled trial.<h4>Setting</h4>21 general practices in England.<h4>Participants</h4>Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.<h4>Intervention and comparator</h4>Usual care plus eith ...[more]

PMID: 28954789

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Project description:IntroductionThe use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context.Methods and analysisThe overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled through advertisment or by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessment, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up.Ethics and disseminationEthical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274 and dnr 2019-05572. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations.Trial registration numberNCT03746873.

Project description:BACKGROUND:Digital health is increasingly recognized as a cost-effective means to support patient self-care. However, there are concerns about whether the "digital divide," defined as the gap between those who do and do not make regular use of digital technologies, will lead to increased health inequalities. Access to the internet, computer literacy, motivation to use digital health interventions, and fears about internet security are barriers to use of digital health interventions. Some of these barriers disproportionately affect people of older age, black or minority ethnic background, and low socioeconomic status. HeLP-Diabetes (Healthy Living for People with type 2 Diabetes), a theoretically informed online self-management program for adults with type 2 diabetes, was developed to meet the needs of people from a broad demographic background. OBJECTIVE:This study aimed to determine whether there was evidence of a digital divide when HeLP-Diabetes was integrated into routine care. This was achieved by (1) comparing the characteristics of people who registered for the program against the target population (people with type 2 diabetes in inner London), (2) comparing the characteristics of people who registered for the program and used it with those who did not use it, and (3) comparing sections of the website visited by different demographic groups. METHODS:A retrospective analysis of data on the use of HeLP-Diabetes in routine clinical practice in 4 inner London clinical commissioning groups was undertaken. Data were collected from patients who registered for the program as part of routine health services.. Data on gender, age, ethnicity, and educational attainment were collected at registration, and data on webpage visits (user identification number, date, time, and page visited) were collected automatically by software on the server side of the website. RESULTS:The characteristics of people who registered for the program were found to reflect those of the target population. The mean age was 58.4 years (SD=28.0), over 50.0% were from black and minority ethnic backgrounds, and nearly a third (29.8%) had no qualifications beyond school leaving age. There was no association between demographic characteristics and use of the program, apart from weak evidence of less use by the mixed ethnicity group. There was no evidence of the differential use of the program by any demographic group, apart from weak evidence for people with degrees and school leavers being more likely to use the "Living and working with diabetes" (P=.03) and "Treating diabetes" (P=.04) sections of the website. CONCLUSIONS:This study is one of the first to provide evidence that a digital health intervention can be integrated into routine health services without widening health inequalities. The relative success of the intervention may be attributed to integration into routine health care, and careful design with extensive user input and consideration of literacy levels. Developers of digital health interventions need to acknowledge barriers to access and use, and collect data on the demographic profile of users, to address inequalities.

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Project description:BackgroundThe increasing prevalence of type 2 diabetes and suboptimal glycaemic control in Kuwait requires novel, wide-reaching, low-cost interventions to motivate and mobilise individuals towards more effective self-management. More than 2 million people in Kuwait own mobile phones. We will test whether automated personalised health text messages based on principles of motivational interviewing and are responsive to biodata delivered remotely is potentially effective in improving glycaemic control compared to usual care.MethodsThis is a two-arm parallel single-blind randomised controlled trial of 572 individuals with type 2 diabetes in Kuwait. We will develop a culturally appropriate database of text messages supporting positive lifestyle changes in type 2 diabetes. A computer programme will deliver over 400 text messages over a 12-month period using algorithms which provide participants with information on diet and physical activity as well as personalised messages regarding motivators to change behaviours. Individuals aged 18-75 years with established type 2 diabetes who are fluent in Arabic or English and officially resident in Kuwait will be identified via screening of hospital diabetes clinic and primary care practices and invited to participate. A sample of 572 participants will be randomised to usual care or usual care plus the DATES text message intervention. Randomisation will be conducted by an independent Clinical Trials Unit and researchers collecting baseline and outcome data will be blinded to treatment allocation. The primary outcome is change in HbA1c and weight at 12 months in both study arms. Secondary outcomes will include changes in physical activity, fasting lipids and quality of life in both study arms.DiscussionThe potential of mobile phones in improving diabetes self-care in settings with a high prevalence of diabetes and widespread mobile phone usage has face validity. Mobile phones and text messaging are an understudied virtual communication media which can deliver discrete focused psychological support to motivate and enable diabetes self-care changes.Trial registrationISRCTN10342151 . 11/03/2015.

Project description:BackgroundMore adolescents with chronic physical illness are living into adulthood, and they require the development of proficient self-management skills to maintain optimal physical health as they transition into adult care services. It is often during this vulnerable transition period that deterioration in illness control is seen as a result of inadequate self-management skills and understanding of their chronic illness. Mobile technology has been proposed as an innovative opportunity to assist in improving the management of chronic conditions as young people transition to adult care services. Over the past 5 years, there has been a significant increase in research into the use of health-related apps.ObjectiveThis study aimed to evaluate the utility and effectiveness of mobile and Web-based health apps that support self-management and transition in young people with chronic physical health illnesses.MethodsWe conducted a comprehensive review of the literature in 5 bibliographic databases, using key search terms, considering only articles published from 2013, as we were extending the data from 2 previous systematic reviews. Abstracts were screened for possible inclusion by 2 reviewers. Data extraction and quality assessment tools were used for the evaluation of included studies.ResultsA total of 1737 records were identified from the combined electronic searches, and 854 records were removed as duplicates. A total of 68 full articles were further assessed for eligibility, and 6 articles met our review criteria: 3 pilot studies, 2 randomized controlled trials, and 1 prospective cohort study. Publication years ranged from 2015 to 2018. The apps reported were targeted at type 1 diabetes mellitus, epilepsy, asthma, beta thalassemia major, and sickle cell disease, with a combined sample size of 336. A total of 4 studies included in this review reported being effective in increasing knowledge of the targeted condition and increasing therapy adherence, including increased medication adherence. A total of 2 manuscripts only mentioned the word transition. Participant's satisfaction was reported for all studies. Heterogeneity of the studies prevented meta-analysis.ConclusionsThere remain limited data on the effectiveness and use of mobile and Web-based apps, which might facilitate the transition of adolescents with chronic illnesses from pediatric to adult health care services. This systematic review provides an updated overview of available apps for adolescents with chronic illnesses. This systematic review has been unable to provide evidence for effectiveness of this approach, but it does provide insights into future study design, with reference to the development, evaluation, and efficacy of apps tailored for adolescents with chronic illnesses, including the involvement of adolescents in such designs.Trial registrationPROSPERO CRD42018104611; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=104611.

Dataset Information

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care.

Objective

Methods and design

Setting

Participants

Intervention and comparator

Outcomes and data collection

Analysis

Results

Conclusions

Trial registration number

Publications

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care.

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