An Enhanced SMS-based Support and Reminder Program for Young Adults with Type 2 Diabetes (TEXT2U): Randomized Controlled Trial.
Ontology highlight
ABSTRACT: Background
Clinic attendance, metabolic control, engagement in self-management and psychological health are suboptimal in young-onset (<40 years) type 2 diabetes.Objective
We examined the effectiveness of an enhanced SMS-based support and reminder program in improving clinic attendance, metabolic control, engagement in self-management and psychological health in young-onset type 2 diabetes.Methods
A twelve-month, parallel-arm, randomized controlled trial comparing an enhanced, semi-personalized SMS-based intervention (incorporating one to eight, supportive and/or informative text messages/month) against standard care was conducted in a specialist, young adult type 2 diabetes clinic. The primary outcome was maintenance of 100% attendance at scheduled quarterly clinical appointments. Secondary outcomes included: (i) metabolic indices, (ii) pathology and self-monitored blood glucose (SMBG) data availability and, (iii) psychosocial well-being.Results
Forty participants were randomized and 32 completed their 12-month study visit. Average participant age was 32.7±5.1 years, 50% were male, and baseline HbA1c was 7.3±1.9% (56±20 mmol/mol). A higher proportion of the intervention group achieved 100% attendance (57% vs 26% control); Kaplan-Meier analysis demonstrated significantly greater cumulative attendance in the intervention group (P=.04). There were no between-group differences in HbA1c, BMI, lipids or availability of pathology and SMBG data. Odds of recording an improvement in Diabetes Empowerment Scale-Short Form score were higher in the intervention group at six months [OR 4.3 (1.1-17)] with attenuation of effect at study end [OR 3.1 (0.9-11)]. Program acceptability was high; >90% of participants would recommend the program to new patients.Conclusions
An enhanced SMS-based support and reminder program doubled scheduled attendance rates for young-onset type 2 diabetes. The program was highly acceptable, provided early support for patient empowerment but had no significant effect on measures of metabolic control or self-management.Clinicaltrial
Australian and New Zealand Clinical Trials Registry (ACTRN12618000479202).
SUBMITTER: Middleton T
PROVIDER: S-EPMC8569538 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.
| S-EPMC3909351 | biostudies-literature
Project description:BackgroundIn Peru's urban communities, tobacco smoking generally starts during adolescence and smoking prevalence is highest among young adults. Each year, many attempt to quit, but access to smoking cessation programs is limited. Evidence-based text messaging smoking cessation programs are an alternative that has been successfully implemented in high-income countries, but not yet in middle- and low-income countries with limited tobacco control policies.ObjectiveThe objective was to assess the feasibility and acceptability of an short message service (SMS) text message-based cognitive behavioral smoking cessation program for young adults in Lima, Peru.MethodsRecruitment included using flyers and social media ads to direct young adults interested in quitting smoking to a website where interested participants completed a Google Drive survey. Inclusion criteria were being between ages 18 and 25 years, smoking at least four cigarettes per day at least 6 days per week, willing to quit in the next 30 days, owning a mobile phone, using SMS text messaging at least once in past year, and residing in Lima. Participants joined one of three phases: (1) focus groups and in-depth interviews whose feedback was used to develop the SMS text messages, (2) validating the SMS text messages, and (3) a pilot of the SMS text message-based smoking cessation program to test its feasibility and acceptability among young adults in Lima. The outcome measures included adherence to the SMS text message-based program, acceptability of content, and smoking abstinence self-report on days 2, 7, and 30 after quitting.ResultsOf 639 participants who completed initial online surveys, 42 met the inclusion criteria and 35 agreed to participate (focus groups and interviews: n=12; validate SMS text messages: n=8; program pilot: n=15). Common quit practices and beliefs emerged from participants in the focus groups and interviews informed the content, tone, and delivery schedule of the messages used in the SMS text message smoking cessation program. A small randomized controlled pilot trial was performed to test the program's feasibility and acceptability; nine smokers were assigned to the SMS text message smoking cessation program and six to a SMS text message nutrition program. Participant retention was high: 93% (14/15) remained until day 30 after quit day. In all, 56% of participants (5/9) in the SMS text message smoking cessation program reported remaining smoke-free until day 30 after quit day and 17% of participants (1/6) in the SMS text message nutrition program reported remaining smoke-free during the entire program. The 14 participants who completed the pilot reported that they received valuable health information and approved the delivery schedule of the SMS text messages.ConclusionsThis study provides initial evidence that a SMS text message smoking cessation program is feasible and acceptable for young adults residing in Lima.
| S-EPMC5562935 | biostudies-literature
Project description:IntroductionMany studies have now demonstrated the efficacy of text messaging in positively changing behaviours. We aimed to identify features and factors that explain the effectiveness of a successful text messaging program in terms of user engagement, perceived usefulness, behavior change and program delivery preferences.MethodsMixed methods qualitative design combining four data sources; (i) analytic data extracted directly from the software system, (ii) participant survey, (iii) focus groups to identify barriers and enablers to implementation and mechanisms of effect and (iv) recruitment screening logs and text message responses to examine engagement. This evaluation was conducted within the TEXT ME trial-a parallel design, single-blind randomized controlled trial (RCT) of 710 patients with coronary heart disease (CHD). Qualitative data were interpreted using inductive thematic analysis.Results307/352 (87% response rate) of recruited patients with CHD completed the program evaluation survey at six months and 25 participated in a focus group. Factors increasing engagement included (i) ability to save and share messages, (ii) having the support of providers and family, (iii) a feeling of support through participation in the program, (iv) the program being initiated close to the time of a cardiovascular event, (v) personalization of the messages, (vi) opportunity for initial face-to-face contact with a provider and (vii) that program and content was perceived to be from a credible source. Clear themes relating to program delivery were that diet and physical activity messages were most valued, four messages per week was ideal and most participants felt program duration should be provided for at least for six months or longer.ConclusionsThis study provides context and insight into the factors influencing consumer engagement with a text message program aimed at improving health-related behavior. The study suggests program components that may enhance potential success but will require integration at the development stage to optimize up-scaling.Trial registrationAustralia and New Zealand Clinical Trials Registry, ACTRN12611000161921.
| S-EPMC5065147 | biostudies-literature
Project description:Background: Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods: A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people. OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results: A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text. Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63). The median time to response was nine days in both groups. In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text. In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions: Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration: ISRCTN22202133; SWAT 35.
| S-EPMC7194505 | biostudies-literature
Project description:We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure.In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care.In this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect.URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141.
| S-EPMC4750295 | biostudies-literature
Project description:OBJECTIVE:mHealth interventions have the potential to facilitate self-management. This TEXT4DSM study implemented a mobile phone intervention in existing diabetes programmes in three low- and middle-income countries (Democratic Republic of Congo, Cambodia, and the Philippines). RESEARCH DESIGN AND METHODS:Sub-studies with a similar randomised controlled trial design were conducted in three different countries. Each sub-study included 480 adults with diabetes. Subjects were randomised to receive either routine care or routine care plus text message self-management support. The primary outcome was the difference in the proportion of subjects with well-controlled diabetes after 2 years. RESULTS:Baseline and 2-year HbA1c measurements were available for 781 individuals. After 2 years, the proportion of subjects with controlled HbA1c was 2.8% higher in the intervention group than in the control group (difference not statistically significant). In the logistic regression model, the odds ratio for having controlled diabetes after the intervention was 1.1, after adjusting for baseline HbA1c level, sex, receiving insulin treatment, and participating in the routine programme. The HbA1c dynamics over time differed between programmes; the number of people with controlled diabetes tended to increase in DR Congo and decrease in Cambodia. CONCLUSION:This study was the first to test the same mHealth intervention in different countries. The finding that text messages did not show an additional effect on diabetes control implied that expectations about mHealth should be cautious. The degree of coverage, the quality of the routine programme, and the progression of disease can interfere with the expected impact. Trial registration: ISRCTN registry (86247213).
| S-EPMC5651290 | biostudies-literature
Project description:Patient reminder systems are an evidence-based way to improve childhood vaccination rates but are difficult to implement in low- and middle-income countries (LMICs). Short Message Service (SMS) texts may offer a potential low-cost solution, especially in LMICs where mobile phones are becoming more ubiquitous.To determine if an SMS-based vaccination reminder system aimed at improving completion of the infant primary immunization series is feasible and acceptable in Guatemala.A pilot randomized controlled trial was conducted at two public health clinics in Guatemala City. Infants aged 8-14 weeks presenting for the first dose of the primary immunization series were enrolled in March-April 2013. Participants randomized into the intervention received three SMS reminders one week before the second and third dose. A follow-up acceptability survey was administered to both groups.The participation rate was 86.8% (321/370); 8 did not own a cell phone and 12 could not use SMS. 96.9% of intervention parents were sent at least one SMS reminder prior to visit 2 and 96.3% prior to visit 3. Both intervention and usual care participants had high rates of vaccine and visit completion, with a non-statistically significant higher percentage of children in the intervention completing both visit 2 (95.0% vs. 90.1%, p=.12) and visit 3 (84.4% vs. 80.7%, p=.69). More intervention vs. usual care parents agreed that SMS reminders would be helpful for remembering appointments (p<.0001), agreed to being interested in receiving future SMS reminders (p<.0001), and said that they would be willing to pay for future SMS reminders (p=.01).This proof of concept evaluation showed that a new application of SMS technology is feasible to implement in a LMIC with high user satisfaction. Larger studies with modifications in the SMS system are needed to determine effectiveness (Clinical Trial Registry NCT01663636).
| S-EPMC4859823 | biostudies-literature
Project description:Importancee-Cigarettes are the most commonly used tobacco product among young adults (YAs). Despite the harms of nicotine exposure among YAs, there are few, if any, empirically tested vaping cessation interventions available.ObjectiveTo determine the effectiveness of a text message program for vaping cessation among YAs vs assessment-only control.Design, setting, and participantsA parallel, 2-group, double-blind, individually randomized clinical trial was conducted from December 2019 to November 2020 among YA e-cigarette users. Eligible individuals were US residents aged 18 to 24 years who owned a mobile phone with an active text message plan, reported past 30-day e-cigarette use, and were interested in quitting in the next 30 days. Participants were recruited via social media ads, the intervention was delivered via text message, and assessments were completed via website or mobile phone. Follow-up was conducted at 1 and 7 months postrandomization; follow-up data collection began January 2020 and ended in November 2020. The study was prespecified in the trial protocol.InterventionsAll participants received monthly assessments via text message about e-cigarette use. The assessment-only control arm (n = 1284) received no additional intervention. The active intervention arm (n = 1304) also received This is Quitting, a fully automated text message program for vaping cessation that delivers social support and cognitive and behavioral coping skills training.Main outcomes and measuresThe primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 7 months analyzed under intention-to-treat analysis, which counted nonresponders as vaping. Secondary outcomes were 7-day ppa under intention-to-treat analysis and retention weighted complete case analysis of 30-day and 7-day ppa.ResultsOf the 2588 YA e-cigarette users included in the trial, the mean (SD) age was 20.4 (1.7) years, 1253 (48.4%) were male, 2159 (83.4%) were White, 275 (10.6%) were Hispanic, and 493 (19.0%) were a sexual minority. Most participants (n = 2129; 82.3%) vaped within 30 minutes of waking. The 7-month follow-up rate was 76.0% (n = 1967), with no differential attrition. Abstinence rates were 24.1% (95% CI, 21.8%-26.5%) among intervention participants and 18.6% (95% CI, 16.7%-20.8%) among control participants (odds ratio, 1.39; 95% CI, 1.15-1.68; P < .001). No baseline variables moderated the treatment-outcome relationship, including nicotine dependence.Conclusions and relevanceResults of this randomized clinical trial demonstrated that a tailored and interactive text message intervention was effective in promoting vaping cessation among YAs. These results establish a benchmark of intervention effectiveness.Trial registrationClinicalTrials.gov Identifier: NCT04251273.
| S-EPMC8129897 | biostudies-literature
Project description:Aims and objectivesYoung adulthood is a life stage comprised of many turning points. For young adults with type 1 diabetes (T1DM), diabetes self-management support is crucial during this period. There is a lack of diabetes education programs and services tailored to this population. This paper presents the findings, according to the STROBE guidelines, on the usability and acceptability of a patient-informed mHealth support program (Diabetes YES) that was developed for young adults with T1DM.MethodsA total of 34 young adults aged 18-35 years with T1DM participated in the Diabetes YES program over 12 weeks. Google analytics was used to tracked website use, while a website usability survey measured ease of use. Facebook analytics was used to measure peer support engagement. Evaluation of the program was completed using Likert scales and open-ended questions.ResultsParticipants rated the website favourably for its ease of navigation and easy to understand information. Web page visits declined sharply while peer support group engagement through Facebook remained consistent throughout the intervention period. Participants utilised weekly discussion topics to generate conversation within the peer support group. Emotional support from peers was the highest regarded benefit reported by participants.ConclusionsDiabetes YES is an example of an mHealth support program that was readily accepted by young adults living with T1DM. Feasibility studies are an important formative step in the implementation of mHealth programs within mainstream healthcare. Future work should focus on the adaptability of such programs to fit within larger consumer or healthcare organisations.
| S-EPMC6796202 | biostudies-literature
Project description:OBJECTIVE:To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes. DESIGN:Nine month, two arm, parallel randomised controlled trial. SETTING:Primary and secondary healthcare services in New Zealand. PARTICIPANTS:366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ?65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control). INTERVENTIONS:The intervention group received a tailored package of text messages for up to nine months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self management and lifestyle behaviours. The control group received usual care. Messages were delivered by a specifically designed automated content management system. MAIN OUTCOME MEASURES:Primary outcome measure was change in glycaemic control (HbA1c) from baseline to nine months. Secondary outcomes included change in HbA1c at three and six months, and self efficacy, diabetes self care behaviours, diabetes distress, perceptions and beliefs about diabetes, health related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at nine months. Regression models adjusted for baseline outcome, health district category, diabetes type, and ethnicity. RESULTS:The reduction in HbA1c at nine months was significantly greater in the intervention group (mean -8.85 mmol/mol (standard deviation 14.84)) than in the control group (-3.96 mmol/mol (17.02); adjusted mean difference -4.23 (95% confidence interval -7.30 to -1.15), P=0.007). Of 21 secondary outcomes, only four showed statistically significant improvements in favour of the intervention group at nine months. Significant improvements were seen for foot care behaviour (adjusted mean difference 0.85 (95% confidence interval 0.40 to 1.29), P<0.001), overall diabetes support (0.26 (0.03 to 0.50), P=0.03), health status on the EQ-5D visual analogue scale (4.38 (0.44 to 8.33), P=0.03), and perceptions of illness identity (-0.54 (-1.04 to -0.03), P=0.04). High levels of satisfaction with SMS4BG were found, with 161 (95%) of 169 participants reporting it to be useful, and 164 (97%) willing to recommend the programme to other people with diabetes. CONCLUSION:A tailored, text message based, self management support programme resulted in modest improvements in glycaemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further investigation into the use of SMS4BG and other text message based support for this patient population. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12614001232628.
| S-EPMC5957049 | biostudies-literature