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Trial registered on ANZCTR


Registration number
ACTRN12620000436976
Ethics application status
Approved
Date submitted
8/03/2020
Date registered
2/04/2020
Date last updated
24/06/2021
Date data sharing statement initially provided
2/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Task sharing management of non-communicable diseases using mobile health in rural India
Scientific title
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
Secondary ID [1] 300682 0
Nil known
Universal Trial Number (UTN)
U1111-1248-9954
Trial acronym
-
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 316486 0
Diabetes 316487 0
Pre-diabetes 316525 0
Anaemia 316526 0
Hyperlipidaemia 316527 0
Obesity 316528 0
Condition category
Condition code
Cardiovascular 314737 314737 0 0
Hypertension
Public Health 314738 314738 0 0
Health promotion/education
Public Health 314739 314739 0 0
Other public health
Cardiovascular 314928 314928 0 0
Other cardiovascular diseases
Metabolic and Endocrine 314929 314929 0 0
Diabetes
Blood 314930 314930 0 0
Anaemia
Diet and Nutrition 314931 314931 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317008 0
Lifestyle
Intervention code [2] 317009 0
Behaviour
Comparator / control treatment
The ASHA will inform all participants about their risk and advise them to visit the nearest primary health centre to receive usual care. The ASHA will provide no further interaction.

In a routine system, medical doctors are responsible for providing treatment of hypertension and management of other complications (co-morbidities) in primary health centres. Doctors also provide follow up advice to patients.
Control group
Active

Outcomes
Primary outcome [1] 323087 0
Between-group change in systolic blood pressure between baseline and 12 months. Standardised blood pressure will be measured after 15 minutes at rest using an Automatic Digital Blood Pressure Monitor and according to a strict protocol.
Timepoint [1] 323087 0
One year after randomisation
Secondary outcome [1] 380743 0
Between-group differences in control of hypertension, i.e. blood pressure less than 140/90 mmHg. This will be determined using a standardised measure of blood pressure after 15 minutes of rest using an Automatic Digital Blood Pressure Monitor and according to a strict protocol.
Timepoint [1] 380743 0
Three months and one year after randomisation
Secondary outcome [2] 380869 0
Between-group differences in adherence to treatment. This will be assessed via self-report (using a questionnaire specifically designed for this study).
Timepoint [2] 380869 0
Three months and one year after randomisation
Secondary outcome [3] 380958 0
Change in health literacy. This will be assessed at baseline, 3 months, and 12 months using the Health Literacy Questionnaire.
Timepoint [3] 380958 0
Baseline measurement as well as the three months and one year after randomisation
Secondary outcome [4] 381025 0
Acceptability of using ASHAs to manage hypertension and vascular risk factors. In-depth interview guides will be used to collect information from patients and health service providers, including auxiliary nurse midwives and doctors, about their perceptions on the care provided by ASHAs
Timepoint [4] 381025 0
One year after randomisation
Secondary outcome [5] 381026 0
Perceptions of patients about the type and availability of support they received from ASHAs. In-depth interview guides will be used to ascertain details from patients about the support provided by ASHAs.
Timepoint [5] 381026 0
One year after randomisation

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Villages are randomised to intervention or usual care using computer randomisation managed centrally. Allocation will be concealed from health workers in that they will not be informed about what is being delivered in the opposing arm of the trial. The patient and outcome assessors remain blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Pre-intervention screening will be used to identify eligible participants:
ASHAs will use an mHealth app, 'Arogya Sahyog' installed on a tablet a device, to screen the participants. The screening will comprise two parts:
Part 1: Identification of people with hypertension, and co-morbidities (diabetes, pre-diabetes, anaemia, and hyperlipidaemia) in those with hypertension, using standardised assessments.
Part 2: Establishing diagnostic accuracy and ascertaining risk.
Those identified with high blood pressure (>139/89 mmHg) will have their blood pressure re-measured, and those with diabetes or pre-diabetes will have their blood glucose re-checked, to confirm the diagnosis. In those with a confirmed diagnosis of hypertension, all participants will be informed about their risk and advised to visit a health centre.

Qualitative interviews:
We will conduct 3-4 in-depth interviews with (i) clinicians and Auxiliary Nurse Midwives (ANM) to determine the acceptability of using ASHAs to manage hypertension and vascular risk factors, and the impact of the new approach on their workload, (ii) ASHAs to determine acceptability of the approach to them and their workload in managing NCDs

3-month and 12-month assessments undertaken by the research team:
At the end of the 3-month and 12-month intervention, we will re-assess blood pressure and other vascular risk factors in both the intervention and usual care groups using independent research team members who are unaware of the group allocation.

Evaluation:
We will undertake a process evaluation to determine factors such as (i) adherence to referral pathways in line with the algorithm in the tablet device, (ii) the type/availability of support received by participants from ASHAs, (iii) assessing patients’ perceptions of the support they received from ASHAs.

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Efficacy of the intervention, e.g. systolic blood pressure (SBP) at follow-up, will be adjusted for baseline levels, by using a mixed-effect regression analysis (clustered by village). All analyses will be based on intention-to-treat. Generalised Estimating Equations (GEE) will be used to study the factors associated with control of hypertension and treatment. The scales of the continuous covariates will be checked for suitability using fractional polynomial plots. Collinearity between variables will be evaluated using partial correlations. In addition, routine diagnostic tests (Hosmer-Lemeshow test) will be used to validate the fitted models.
A content analysis approach will be adopted to analyse qualitative data. All the interviews and field notes from all in-depth interviews will be recorded and transcribed verbatim. A master code-list will be generated, based on which the rest of the transcripts will be coded. We will use NVivo qualitative data analysis software (QSR International Pty Ltd. Version 12, 2018).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
30/12/2021
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 22406 0
India
State/province [1] 22406 0
Uttarakhand

Funding & Sponsors
Funding source category [1] 305156 0
University
Name [1] 305156 0
Monash University
Country [1] 305156 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton 3800
Victoria
Country
Australia
Secondary sponsor category [1] 305518 0
None
Name [1] 305518 0
Address [1] 305518 0
Country [1] 305518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305523 0
Garwhal Community Development and Welfare Society Chamba
Ethics committee address [1] 305523 0
Ethics committee country [1] 305523 0
India
Date submitted for ethics approval [1] 305523 0
18/10/2019
Approval date [1] 305523 0
31/10/2019
Ethics approval number [1] 305523 0
GCDWS/AROGYA/ETHICAL

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100562 0
Prof Amanda Thrift
Address 100562 0
Department of Medicine,
School of Clinical Sciences at Monash Health, Monash University
Clayton, VIC 3168, Melbourne, Australia
Country 100562 0
Australia
Phone 100562 0
+61385722656
Fax 100562 0
Email 100562 0
amanda.thrift@monash.edu
Contact person for public queries
Name 100563 0
Sojib Bin Zaman
Address 100563 0
Department of Medicine,
School of Clinical Sciences at Monash Health, Monash University
Clayton, VIC 3168, Melbourne, Australia
Country 100563 0
Australia
Phone 100563 0
+61 414026891
Fax 100563 0
Email 100563 0
sojib.zaman@monash.edu
Contact person for scientific queries
Name 100564 0
Amanda Thrift
Address 100564 0
Department of Medicine,
School of Clinical Sciences at Monash Health, Monash University
Clayton, VIC 3168, Melbourne
Country 100564 0
Australia
Phone 100564 0
+61385722656
Fax 100564 0
Email 100564 0
amanda.thrift@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 12 months and ending 5 years following main results publication
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (amanda.thrift@monash.edu)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.