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Task sharing management of non-communicable diseases using mobile health in rural India

Effectiveness of a package of lifestyle intervention, delivered by community health workers, to control non-communicable diseases in rural India: A cluster randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000436976
Acronym
-
Enrollment
700
Registered
2020-04-02
Start date
2021-09-01
Completion date
2021-12-30
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Accredited Social Health Activists (ASHAs), who are female community health workers in India, may be used to screen populations for hypertension, prediabetes, diabetes and cancer. These ASHAs will identify and refer cases to sub centres. First, they will complete a community-based assessment checklist for males and females aged 30 years and above. To enable ASHAs to be supported when they are on their own in the community, we have developed a mobile health (mHealth) application 'Arogya Sahyog' [in Hindi 'Health Assistant'} to be installed on a tablet. This mHealth app is designed to help ASHAs to screen, provide lifestyle advice, and refer critical patients to primary care physicians. We will teach ASHAs about NCDs so that they can motivate people to adhere to healthy lifestyle activities. We will also test whether this training programme improves ASHAs knowledge of NCDs. We will further randomise an equal number of ASHAs to either the intervention group or usual care group using a cluster randomised controlled trial (cRCT) design. Participants in the intervention group will receive a fortnightly group-based educational intervention for three months, followed by three-monthly monitoring support for a further nine months. The outcome in this group will be compared to those receiving usual care. This will enable us to test whether mobilising this ASHA workforce results in better management of hypertension and diabetes in a rural area of India. We will further evaluate ASHAs capacity to provide health promotional interventions to patients with, or at risk of, NCDs using the tablet device.

Interventions

The intervention group will receive two main components of the intervention. The overall duration of the intervention will be 12 months (Step A for 3 months and step B for 9 months). The first 3 months will involve Step A and step B will begin immediately on completion of step A. Step A: Group-based education will be delivered by an Accredited Social Health Activist (ASHA) focusing on various aspects of knowledge to manage hypertension and comorbid conditions fortnightly up to three months (six

The intervention group will receive two main components of the intervention. The overall duration of the intervention will be 12 months (Step A for 3 months and step B for 9 months). The first 3 months will involve Step A and step B will begin immediately on completion of step A. Step A: Group-based education will be delivered by an Accredited Social Health Activist (ASHA) focusing on various aspects of knowledge to manage hypertension and comorbid conditions fortnightly up to three months (six meeting sessions). She will perform a routine check-up and provide health education to all enrolled participants living in her village. Step A will be conducted in a community hall, or similar. Each meeting session will consist of two activities. Firstly, the ASHA will measure blood pressure (BP), heart rate, and weight of the participants. The ASHA will also inquire about their last visit to the health and wellness centre for managing hypertension and assess their current adherence to prescribed medications. The ASHA will use a tablet device (The Arogya Sahyog application) to store these data and let the participant know how s/he is doing with regard to management of blood pressure. Secondly, she will conduct group-based education sessions. The sessions will last for ~ 90 minutes and include the following activities. • Introduction: ASHAs will teach participants about risk factors, their consequences, and management • Self-management education: ASHAs will advise the participants on dietary changes and adherence to medications. • Physical activity: ASHAs will instruct the participants to increase their physical activity. ASHAs will also advise on the type, frequency, and intensity of various exercises that can help them to reduce weight and keep healthy. • Nutrition and diet: ASHAs will advise the participants to eat more grains, vegetables, fruits, and reduce consumption of salt, sugar, and alcohol. • Practical self-management: ASHAs will implement SMART (Specific, Measurable, Attainable, Relevant, Timely) goal-setting and monitor the progress of the participants to support the self-management of risk factors. Step B: The ASHA will visit participants' homes for providing 3-monthly monitoring of BP and risk factors for nine months. This will be a one-on-one monitoring activity. Each 3-monthly visit will include monitoring targets for BP and other relevant risk factors, adherence to medication, and providing one-on-one self-management support. These tasks are simplified for the ASHA with the use of the simple management and referral algorithm built within the tablet device. When risk factors are poorly controlled at each visit, the ASHA will refer patients to a health and wellness centre. Each participant will be visited by the ASHA for ~ 30 minutes.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Participants aged 30 years and above 2. Systolic blood pressure greater than 139 mmHg and/or diastolic arterial pressure greater than 89 mmHg or prescription of antihypertensive medications.

Exclusion criteria

1. Critical patients who require immediate referral to a tertiary care facility 2. Patients with vision or hearing impairments 3. Patients who do not intend to stay in the study catchment area for one year

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026