Clinical trial NCT06623006: Self Management of Type 2 Diabetes Using a Text Based Mobile Health (mhealth) Intervention in Nepal
Official title: Self Management of Type 2 Diabetes Using a Co-designed Mobile Health (mhealth) Intervention in Nepal: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: type 2 diabetes, mhealth, self-management, Nepal
Lead sponsor: University of Huddersfield
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: The global prevalence of diabetes is increasing particularly in low and middle income countries like Nepal with the number expected to rise in the near future. Advances in technology have led to greater use of mobile health (mhealth) for managing chronic diseases. mhealth offers a cost-effective way to improve health outcomes with evidence supporting feasibility, acceptability and effectiveness in resource-limited settings like Nepal. However, while mhealth has shown promising results in promoting positive health behaviour and improving service utilization for chronic conditions, its potential for self-management of type 2 diabetes in Nepal is yet to be evaluated. This study thus aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes in Nepal.

Methods: This study is a 6 month, open-label, two-armed parallel group randomized control trial among 154 participants with type 2 diabetes. Participants will be randomly assigned to either intervention or control group on a 1:1 basis. The intervention group will receive a text based mhealth intervention (text messages) in addition to standard care while the control group will receive only standard care. Baseline data will be collected using a structured questionnaire. Follow up will be done 6 months after the intervention. The primary outcome of the study will be a difference in mean in the HbA1c level from baseline to follow up. The secondary outcomes include changes in diabetes self-care activities, self-efficacy, social-support, diabetes related stress, quality of life and acceptability of the intervention. An economic evaluation will be conducted using a patient perspective. Data will be analyzed using Stata version 13.0.

Detailed description: Background and rationale The number of people living with diabetes has increased globally and is on rapid rise among low and middle income countries (LMICs). In 2021, there were 537 million people living with diabetes and this number is expected to rise to 643 million by 2030 and 783 million by 2045. More than three in four adults with diabetes are living in LMICs. Diabetes accounted for 6.6 million deaths in 2021 and is a major cause of blindness, kidney failure, heart attack, stroke and lower limb amputation. Following the global trend, the prevalence of diabetes has been increasing in Nepal. The International Diabetes Federation (IDF) estimated a prevalence of 8.7% among Nepalese population and the proportion is to rise to 9.4% by 2045.

The burgeoning burden of disease may place serious challenges on the resource constrained national health system due to complications resulting from the disease, coupled with issues around service availability; readiness and limited awareness among the people living with diabetes.

Access to care is of utmost importance for people with diabetes in the course of their disease however, the availability and utilisation of diabetes care services vary across socio-economic and geographical distribution indicating challenges in accessing the diabetes care services. WHO STEPS survey Nepal 2019 reported about three-fourth (73.5%) of the people were not aware of their raised blood sugar. Despite being aware of their condition, about 6% were not on treatment. Similarly, only 70% of adults with raised blood sugar reported compliance to medications to control their blood sugar. In addition, public health facilities in Nepal are not ready to deal with the increasing burden of NCDs including diabetes in terms of qualified health staff, training, availability of equipment and medicines as well as availability of diabetes services in general.

Early diagnosis, treatment and self-management are essential for the prevention and control of the disease. Self-management refers to the activities and behaviour undertaken by the individuals to control and treat their conditions to improve their health outcomes with support from family members, friends and relatives and in consultation with health service providers. The American Association of Diabetes Educators (AADE) has identified seven self-care behaviours for successful and effective self-management of diabetes as healthy coping, healthy eating, being active, taking medication, monitoring, reducing risks and problem solving. Self-management has been proved to be cost effective through reduction in hospital admissions and health care costs. Besides, it is shown to improve HbA1c level and has a positive effect on other clinical, psychosocial, and behavioural aspects of diabetes along with improvement in quality of life by reducing onset and/or advancement of diabetes complications.

With the development of technology, the application of mobile health (mhealth) is becoming increasingly popular in the self-care of chronic diseases. mhealth interventions have been proved to be a therapeutic strategy that could improve the diabetes management despite their economic status. According to the National Population and Housing Census report 2021, about three-fourth (73%) of the households have at least some form of smartphone penetration and 37.9% household with internet access in Nepal.

In the resource limited countries like Nepal, mhealth technology can be a cost-effective approach to deliver care and improve the health outcomes. There are studies demonstrating the feasibility, acceptability and even effectiveness of mhealth in improving the health outcomes for hypertension in Nepal. There is also existing evidence of mhealth as an effective means to communicate health related information and supporting positive behaviour change in a short period of time. Despite availability of body of evidence on acceptability of mhealth in improving service utilization and health outcomes for chronic conditions, the application of behaviour change interventions through mhealth for self-management of diabetes is yet to be evaluated.

Objectives This study aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes using a co-designed approach in Nepal.

Objective 1: To determine effectiveness and cost effectiveness of text based mhealth intervention in improving self-management (HbA1c level, self-efficacy, perceived support, diabetes related stress, health related quality of life and self-care behaviors) Objective 2: To determine acceptability of a text based mhealth intervention in improving self-management among people with type 2 diabetes

Eligibility criteria: Inclusion Criteria:

* adults aged 18 years and above
* clinical diagnosis of type 2 diabetes
* participant who have a mobile phone and is able to read the message on their own or with the help of family members.

Exclusion Criteria:

* not physically or mentally able, not able to provide consent
* pregnant in case of female

Primary outcomes:
measure: Change in HbA1c level
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Kavrepalanchowk
country: Nepal
facility: Dhulikhel Hospital
state: Bagmati
Study officials:
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