How To Manage Diabetes Effectively – Research Effectiveness of a text message-based support program for diabetes self-management (SMS4BG): a two-arm, parallel randomized controlled trial 2018; 361 doi: https://doi.org/10.1136/.k1959 (published 17 May 2018) Cite as: 2018; 361:k1959 Linked commentary The potential of mobile health – reaching those in need
Objective To determine the effectiveness of a theoretically based, individually tailored, text message-based diabetes self-management support intervention (SMS4BG) in adults with poorly controlled diabetes.
366 participants aged 16 years and older with type 1 or type 2 diabetes (HbA1c ≥65 mmol/mol or 8%) were randomized between June 2015 and November 2016 (n=183 intervention, n=183 control).
Interventions In addition to the usual care, the intervention group received a special package of text messages for up to nine months. Text messages provided information, support, motivation, and reminders related to diabetes self-management and lifestyle behaviors. The control group received usual care. Posts are delivered by a specially designed automated content management system.
Main Outcome Measures The primary outcome measure was change from baseline to nine months in glycemic control (HbA1c). Secondary outcomes included change in HbA1c at three and six months, self-efficacy, diabetes, perceptions and beliefs about diabetes, health-related quality of life, support for diabetes management, nine-month intervention, and satisfaction. . Regression models were adjusted for baseline outcome, health district category, type of diabetes, and ethnicity.
Results. % confidence interval -7.30 to -1.15 to), P=0.007). Only four of the 21 secondary outcomes showed statistically significant improvements in favor of the intervention group at nine months. Significant improvements were seen in foot care behaviors (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), and health status on EQ 5D visual analogue scale (4.38 (0.44 to 8.33), P = 0.03) and perceptions of illness recognition (-0.54 (-1.04 to -0.03), P = 0.04) . A high level of satisfaction was found with SMS4BG, with 161 (95%) of 169 participants reporting that it was useful, and 164 (97%) willing to recommend the program to other people with diabetes.
Conclusion: A text message-based, self-management support program produced modest improvements in glycemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further research into the use of SMS4BG and other text message-based supports for this patient population.
The increasing prevalence of diabetes is considered one of the biggest global health problems.1 People from ethnic minorities, including Pacific and Maori (New Zealand indigenous people) groups, are particularly vulnerable to the development of diabetes, experience poor control, and are increasing rate of complications.23456 In New Zealand, 29% of people with diabetes were found to have poorly controlled HbA1c levels (≥65 mmol/mol or 8%). Good blood glucose control can prevent or delay diabetes complications, which not only improves a person’s quality of life, but can also significantly reduce health costs associated with treating or managing complications.89101112
The flexibility of mobile phones and their adoption in everyday life means they are a great tool to support people with diabetes, whose condition requires ongoing management. Effectively used to support diabetes management, mobile phones 13141516 offer an ideal way to provide care with the intensity that the patient needs. Additionally, they can provide effective support methods for patients in rural and remote locations where access to healthcare providers may be limited. 1718 Although there is growing support for the use of mobile health (mHealth) in diabetes, evidence of a digital divide, with less use of certain technologies in specific population groups. 1920 of these groups include those with low health literacy, 21 low income and 222324 members of ethnic minorities. Available tools, lack of local information, cost, literacy, language barriers and lack of cultural compatibility. The greatest support considering these factors.
The SMS4BG (Self-Management Support for Blood Glucose) intervention was developed to address the need for innovative solutions to support self-management in adults with poorly controlled diabetes. 28 An individually tailored intervention provides information and support that motivates an individual to participate in the behavior. Effective management of their diabetes is necessary for long-term health improvement. The development of the SMS4BG mHealth development and evaluation framework 29 (including extensive formative work and end-user engagement to ensure it meets the needs of the population it is designed to reach) is evidence- based and theoretically grounded. A previous pilot study found SMS4BG acceptable and useful.28 This study aimed to determine the effectiveness of an mHealth diabetes self-management support program-SMS4BG in adults with poorly controlled type 1 or type 2 diabetes. Diabetes care.
A nine-month, two-arm, parallel, randomized controlled trial was conducted between June 2015 and August 2017 in adults with poorly controlled diabetes. The study received ethical approval from the Health and Disability Ethics Committee (14/STH/162). 30 was published and registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614001232628). Trial development and reporting were guided by the CONSORT31 and CONSORT EHEALTH32 statements.
Participants were referred to the study by health care professionals in their primary and secondary care centers throughout New Zealand. Participants can also refer to self-study. Eligible participants were English-speaking adults aged 16 years and older with poorly controlled type 1 or 2 diabetes (glycated hemoglobin (HbA1c) concentration ≥65 mmol/mol or 8% in the previous nine months). The first protocol required an HbA1c concentration above the cutoff level within the last three months, but after feedback from patients and doctors, this period was extended to nine months to ensure a greater range in people without regular testing. Participants will have access to a mobile phone and be available for the nine month study period.
Eligible participants were randomized in a 1:1 ratio to an intervention or control group. Randomization was stratified by health district category (high urban or high rural/remote), diabetes type (1 or 2) and ethnicity (Māori and Pacific, or non-Māori/non-Pacific). The randomization sequence was generated by a computer program with two to four variable block sizes and was supervised by the study statistician. After participant consent and completion of the baseline interview, the research assistant randomized the participant to intervention or control using the REDCap randomization module. The REDCap randomization module ensured that treatment allocation was concealed until the randomization phase. Due to the nature of the intervention, participants were aware of their treatment allocation. Research assistants conducting telephone interviews were also aware of treatment allocation. However, the objective primary outcome was measured by blinded assessors throughout the study period.
Participants referred for the study by clinicians or self-referred were contacted by phone by a research assistant to discuss the study and confirm eligibility. All eligible participants completed informed consent and then completed a baseline assessment by telephone with a research assistant prior to randomization. All participants continued their usual diabetes care throughout the study, including all medical visits, tests and diabetes support programs. In addition, the intervention group received SMS4BG. Control participants received usual care only. All participants completed a follow-up telephone interview nine months after randomization (within three weeks of the nine-month date). HbA1c blood tests (at baseline, three, six and nine months) were performed by standard care and results obtained from medical records.
SMS4BG is an automated self-management support program that provides SMS (short message service) to motivate and support people to engage in the behaviors required for successful diabetes management. The program is tailored to the needs, goals and demographic factors of the individual. Key motivational and supportive messages (in Māori, Pacific, or non-Māori/Pacific cultural versions), and participants can choose to receive additional modules including: insulin control, elder support, smoking cessation, and lifestyle behaviors (exercise, healthy eating, or stress/mood management). , foot protection (more module details in Supplementary Table 1).
Participants can choose to receive blood glucose monitoring reminders and respond to them by sending their results via text message. They can view their results graphically over time on a password-protected website. If they were identified as having no internet access at baseline, their graphs were mailed once a month. All messages were delivered in English, although the Maori version contained keywords in Te Reo Māori, while the Pacific version contained keywords in Samoan or Tongan languages, depending on ethnicity. Examples of SMS4BG messages can be found in the box. Participants could choose the time
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