Scalable solution for delivery of diabetes self-management education in Thailand (DSME-T): a cluster randomised trial study protocol.

INTRODUCTION: Type 2 diabetes mellitus is among the foremost health challenges facing policy makers in Thailand as its prevalence has more than tripled over the last two decades, accounting for considerable death, disability and healthcare expenditure. Diabetes self-management education (DSME) programmes show promise in improving diabetes outcomes, but this is not routinely used in Thailand. This study aims to test a culturally tailored DSME model in Thailand, using a three-arm cluster randomised controlled trial comparing a nurse-led model, a peer-assisted model and standard care. We will test which model is effective and cost effective to improve cardiovascular risk and control of blood glucose among people with diabetes. METHODS AND ANALYSIS: 21 primary care units in northern Thailand will be randomised to one of three interventions, enrolling a total of 693 patients. The primary care units will be randomised (1:1:1) to participate in a culturally-tailored DSME intervention for 12 months. The three-arm trial design will compare effectiveness of nurse-led, peer-assisted (Thai village health volunteers) and standard care. The primary trial outcomes are changes in haemoglobin A1c and cardiovascular risk score. A process evaluation and cost effectiveness evaluation will be conducted to produce policy relevant guidance for the Thai Ministry of Public Health. The planned trial period will start in January 2020 and finish October 2021. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Thailand and the UK. We will share our study data with other researchers, advertising via our publications and web presence. In particular, we are committed to sharing our findings and data with academic audiences in Thailand and other low-income and middle-income countries. TRIAL REGISTRATION NUMBER: NCT03938233

Socially assistive robots in health and social care: Acceptance and cultural factors. Results from an exploratory international online survey

Aim: This study explored the views of an international sample of registered nurses and midwives working in health and social care concerning socially assistive robots (SARs), and the relationship between dimensions of culture and rejection of the idea that SARs had benefits in these settings. Methods: An online survey was used to obtain rankings of (among other topics) the extent to which SARs have benefits for health and social care. It also asked for free text responses regarding any concerns about SARs. Results: Most respondents were overwhelmingly positive about SARs' benefits. A small minority strongly rejected this idea, and qualitative analysis of the objections raised by them revealed three major themes: things might go wrong, depersonalization, and patient‐related concerns. However, many participants who were highly accepting of the benefits of SARs expressed similar objections. Cultural dimensions of long‐term orientation and uncertainty avoidance feature prominently in technology acceptance research. Therefore, the relationship between the proportion of respondents from each country who felt that SARs had no benefits and each country's ratings on long‐term orientation and uncertainty avoidance were also examined. A significant positive correlation was found for long‐term orientation, but not for uncertainty avoidance. Conclusion: Most respondents were positive about the benefits of SARs, and similar concerns about their use were expressed both by those who strongly accepted the idea that they had benefits and those who did not. Some evidence was found to suggest that cultural factors were related to rejecting the idea that SARs had benefits

Using a Randomised Controlled Trial to Test the Effectiveness of a Family-Oriented, Theoretically Based, Diabetes Self-Management Education Program to Improve Glycaemia, Self-Management and Self-Efficacy of Individuals with Type 2 Diabetes Mellitus Living in Rural Thailand

Introduction Diabetes is increasing in prevalence throughout the world. This increase is also of concern to upper-middle-income countries such as Thailand. Diabetes mellitus develops gradually and is often undetected in the early stages, leading to long-term damage of several organs in the body with related complications. Diabetes self-management education (DSME) has been found to improve knowledge, self-care behaviours, glycaemic control, and quality of life for Thai individuals with type 2 diabetes mellitus (T2DM). Thailand is a country in which family members have a fundamental role in assisting other family members in sickness and in health. Family-oriented interventions, therefore, have the potential to enhance health outcomes for individuals with T2DM. Randomised controlled trials conducted on family-carers of individuals with diabetes in Thailand are limited and none has investigated the potential benefit of a family-oriented DSME program, which includes the family-carer in the intervention. Aims The primary aim of this study was to test the effectiveness of a family-oriented, theoretically derived (based on self-efficacy) DSME for Thai individuals living with T2DM. The specific objectives of this research are to develop and deliver a family-oriented DSME for Thai individuals with T2DM and carers; to evaluate the effectiveness of a family-oriented DSME in improving diabetes knowledge, glycaemic control, self-efficacy, self-management, and quality of life among Thai individuals with T2DM; to develop and test the validity and reliability of the family-carer diabetes management self-efficacy scale (F-DMSES) that measures diabetes management self-efficacy among family-carers of Thai individuals with T2DM; and, finally, to measure and compare diabetes management self-efficacy between individuals with T2DM and their carers. Methods After developing a family-oriented DSME program, a single-blinded randomised controlled trial was conducted in rural Thailand to examine the effectiveness of the program. One hundred and forty Thai individuals with T2DM (and their carers) were randomly allocated to intervention and control arms. Those in the intervention group received routine care plus the family-oriented program that included education classes, group discussions, a home visit, and a telephone follow-up. Participants within the control group only received the routine usual care. The sample size was estimated based on a known effect size (effect size = 0.58) from the primary outcome of diabetes self-management score (Mean difference = 8.35, SD = 14.28) (Wu et al., 2011). The level of significance was set at 0.05 (probability of type 1 error) and a power of 0.90 (1- probability of type 2 error), and a sample of 140 people (70 per group) was required. The primary study outcome was diabetes self-management evaluated by the Summary of Diabetes Self-Care Activities measure. The secondary outcomes were diabetes knowledge evaluated by the Diabetes Knowledge Questionnaire, diabetes self-efficacy (efficacy expectation and outcome expectation) evaluated by the Diabetes Management Self-Efficacy Scale and the Perceived Therapeutic Efficacy Scale, quality of life evaluated by the 12-item Short-Form Health Survey, and glycaemic control as shown by HbA1C levels. Outcome assessments were made overtime (baseline, week 5 and week 13 following intervention) and were evaluated using generalised estimating equations multivariable analyses. The family-carer diabetes management self-efficacy scale (F-DMSES) was developed using forward and backward translations from and to English and Thai languages and its construct and content validity, together with the internal consistency, were tested. Results One hundred and forty participants were actually recruited and randomized to the intervention but 134 individuals have completed the three time points in data collection. Intention to-treat analyses were conducted in this study. Except for age, no between-group significant differences were found in all other baseline characteristics. Diabetes self-efficacy, self-management, and quality of life improved in the intervention group but no improvement was observed in the controls. In the risk-adjusted multivariable models, compared to the controls, participants in the intervention group had significantly better self-efficacy, self-management, outcome expectations, and diabetes knowledge (p < 0.001 for all outcomes). Participation in the intervention increased the diabetes self-management score by 14.3 points (β = 14.3, (95% CI 10.7 – 17.9), p < 0.001). Self-management improved in individuals with lower BMIs and in females. No between-group differences were observed in quality of life or glycaemic control. The F-DMSES retained 14 items within 4 factors (general diet and blood glucose monitoring, medications and complications, diet in differing situations, and weight control and physical activities), and explained 72.2% of the total variance in the overarching construct. Internal consistency was high (α = 0.89). The F-DMSES was also able to measure change over time following the intervention, with an effect size of 0.9. Diabetes knowledge and management self-efficacy in family-carers improved over time. These aspects were also improved in individuals with T2DM when compared to their carers. Conclusions The family-oriented DSME program improved self-efficacy, self-management and quality of life, which in turn could decrease HbA1c levels. The F-DMSES is a valid and reliable self-administered instrument that measures the diabetes management self-efficacy of family-carers of individuals with T2DM, which can be used in clinical and research situations. Better carer diabetes knowledge improved the self-management of individuals with T2DM and greater family-carer diabetes management self-efficacy increased the diabetes management self-efficacy of individuals with T2DM. Family-carers can play an important role in supporting individuals with T2DM living in Thailand and should be formally included within educational programs. Family-carers also have the potential to provide compensatory care when required

Psychometric testing of the Family-Carer Diabetes Management Self-Efficacy Scale

The aim of this study was to develop and test the construct and content validity, internal consistency of the Family‐Carer Diabetes Management Self‐Efficacy Scale (F‐DMSES). A sample of 70 Thai individuals who cared for those living with type 2 diabetes mellitus (T2DM) in a rural community in Thailand was included in the study. Data were collected by a questionnaire survey in January 2014. The F‐DMSES was initially derived from the DMSES, with subsequent forward and backward translations from and to English and Thai languages. The psychometric properties (content, construct and internal consistency) of the Thai version were explored using the Content Validity Index approach, exploratory factor analysis and Cronbach's alpha test. The F‐DMSES initially designed with 20 items was reduced to 14 items within four factors (general diet and blood glucose monitoring, medications and complications, diet in differing situations, and weight control and physical activities), and explained 72.2% of the total variance in overarching construct. Internal consistency was supported (α = 0.89). The F‐DMSES was also able to measure change over time following an intervention, with an effect size of 0.9. The F‐DMSES is a valid and reliable self‐administered instrument that measures the diabetes management self‐efficacy of family‐carers of individuals with T2DM. This instrument can be used in practice and clinical trials to assess the impact of family‐carers on the health outcomes of individuals with T2DM

Randomized controlled trial of a family-orientated self-management program to improve self-efficacy, glycemic control, and quality of life among Thai individuals with Type 2 Diabetes

Aims: We evaluated a theoretically-derived family-oriented intervention aimed to improve self-efficacy, self-management, glycemic control and quality of life in individuals living with Type 2 diabetes in Thailand. Methods: In a single-blinded randomized controlled trial, 140 volunteer individuals with Type 2 diabetes, recruited from a diabetes clinic in rural Thailand, were randomly allocated to intervention and control arms. Those in the intervention arm received routine care plus a family-oriented program that included education classes, group discussions, a home visit, and a telephone follow-up while the control arm only received routine care. Improvement in outcomes over time (baseline, Week 3, and Week 13 following intervention) was evaluated using Generalized Estimating Equations multivariable analyses. Results: Except for age, no between-group significant differences were observed in all other baseline characteristics. Diabetes self-efficacy, self-management, and quality of life improved in the intervention arm but no improvement was observed in the controls. In the risk-adjusted multivariable models, compared to the controls, the intervention arm had significantly better self-efficacy, self-management, outcome expectations, and diabetes knowledge (p < 0.001, in each). Participation in the intervention increased the diabetes self-management score by 14.3 points (β = 14.3, (95% CI 10.7–17.9), p < 0.001). Self-management was better in leaner patients and in females. No between-group differences were seen in quality of life or glycemic control, however, in the risk-adjusted multivariable models, higher self-management scores were associated with significantly decreased HbA1c levels (p < 0.001) and improved patient quality of life (p < 0.05) (irrespective of group membership). Conclusions: Our family-oriented program improved patients’ self-efficacy and self-management, which in turn could decrease HbA1c levels

Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T).

INTRODUCTION: Type 2 diabetes mellitus is a major global challenge, including for Thai policy-makers, as an estimated 4 million people in Thailand (population 68 million) have this condition. Premature death and disability due to diabetes are primarily due to complications which can be prevented by good risk factor control. Diabetes Self-Management Education (DSME) programmes provide patients with diabetes with the necessary knowledge and skills to effectively manage their disease. Currently, a trial is being conducted in Thailand to evaluate the effectiveness, defined as HbA1c<7 at 12 months after enrolment, of a culturally tailored DSME in Thailand. A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context. METHODS AND ANALYSIS: The aim of the process evaluation is to understand how and why the intervention was effective or ineffective and to identify contextually relevant strategies for future successful implementation. For the process evaluation, the design will be a mixed-method study collecting data from nurse providers, and village health volunteers (community health workers) as well as patients. This will be conducted using observations, interviews and focus groups from the three purposively selected groups at the beginning and end of trial. Quantitative data will be collected through surveys conducted at the beginning, during 6-month follow-up, and at the end of trial. The mixed-methods analysis will be triangulated to assess differences and similarities across the various data sources. The overall effectiveness of the intervention will be examined using multilevel analysis of repeated measures. ETHICS AND DISSEMINATION: Study approved by the Chiang Mai University Research Ethics Committee (326/2018) and the London School of Hygiene & Tropical Medicine (16113/RR/12850). Results will be published in open access, peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT03938233

Socially assistive robots in health and social care: Acceptance and cultural factors. Results from an exploratory international online survey

This study explored the views of an international sample of registered nurses and midwives working in health and social care concerning socially assistive robots (SARs), and the relationship between dimensions of culture and rejection of the idea that SARs had benefits in these settings

Views about perceived training needs of health care professionals in relation to socially assistive robots: an international online survey

As Artificial Intelligence and social robots are increasingly used in health and social care, it is imperative to explore the training needs of the workforce, factoring in their cultural background