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Trial registered on ANZCTR
Registration number
ACTRN12625000920493p
Ethics application status
Not yet submitted
Date submitted
16/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Testing a New Community Health Worker Program to Help Disadvantaged People with Multiple Long-Term Health Conditions in Eastern Nepal
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Scientific title
Implementation and evaluation of a novel Codesigned Integrated Multimorbidity Management by Community Health Workers (CIMM-CHW) intervention targeting People with Multiple Long-Term Health Conditions in disadvantaged communities in eastern Nepal- Type II hybrid implementation trial
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Secondary ID [1]
314912
0
None
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Universal Trial Number (UTN)
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Trial acronym
CIMM-CHW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multimorbidity (the presence of multiple long-term conditions in one person)
338228
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Hypertension (high blood pressure)
338229
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Diabetes ( type 2 diabetes)
338230
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Chronic Obstructive Pulmonary Disease (COPD)
338231
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Condition category
Condition code
Cardiovascular
334505
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0
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Hypertension
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Cardiovascular
334506
334506
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0
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Coronary heart disease
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Metabolic and Endocrine
334507
334507
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0
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Diabetes
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Cardiovascular
334508
334508
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study will implement a Codesigned Integrated Multimorbidity Management by Community Health Workers (CIMM-CHW) intervention.
Co-design of CIMM-CHW intervention: Diverse stakeholders, including individuals with multimorbidity, family members, CHWs, clinicians, community leaders, and policymakers, will engage in a 16-month co-design process. A three-day workshop with 15-20 stakeholders, with 3-4 representatives from
each stakeholder category, will be conducted.
Day 1 will involve 2.5hr roundtable discussion to map ongoing multimorbidity programs in Nepal.
Day 2 will involve full day (6 hrs workshop) focus on core intervention components, including training manuals, implementation plans, and evaluation strategies, emphasising modifications for cultural appropriateness.
On day 3, On day 3, stakeholders will identify individual and system-level barriers and facilitators for the intervention's implementation plan and develop risk-mitigating strategies.
The key features of CIMM-CHW intervention are:
What CIMM-CHW intervention involves:
Training and revitalising CHWs: They receive ~80–100 hours of training on multimorbidity management, patient education, behaviour change counselling, monitoring symptoms, and culturally appropriate care.
Patient-centred self-management support: CHWs provide monthly 1 hr home visits for symptom monitoring (blood glucose, blood pressure, COPD symptoms). counselling on healthy behaviours, and health literacy. CHWs will also educate patients and their families on multimorbidity, its implications, and selfmanagement strategies for additional 1 hr.
Peer-supported lifestyle interventions: CHWs work with trained peer leaders to run monthly 2-hr community sessions on healthy eating, smoking cessation, alcohol moderation, and physical activity.
Case management and referrals: CHWs coordinate care, refer patients to higher-level health facilities when needed, and help patients navigate social support services.
Who delivers it:
Trained Community Health Workers (CHWs) — including auxiliary health workers, community medical assistants, and Female Community Health Volunteers within Nepal’s primary healthcare system.
Model of delivery: Interactive hands-on structured. workshop
Frequency of training: CHWs will be trained for multimorbidity management over 4 weeks with breaks and quarterly refresher training sessions for CHWs will be considered periodically to reinforce skills and update knowledge on the latest guidelines and practices
Who receives it:
Adults aged 30–70 with two or more chronic conditions (hypertension, diabetes, and/or COPD) in eastern Nepal, especially disadvantaged groups (Indigenous people, Dalits, Madhesis).
Duration and format:
The intervention is delivered over an 18-month period through home visits, group sessions, and community events.
Control group:
Usual care through the existing health system without the enhanced CIMM-CHW support.
This co-designed, culturally adapted approach aims to improve health literacy, patient self-management, and health outcomes for people with multiple chronic conditions.
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Intervention code [1]
331517
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Early detection / Screening
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Intervention code [2]
331518
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Prevention
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Intervention code [3]
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Behaviour
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Comparator / control treatment
Usual care:
Participants in the control arm will continue to receive the standard primary healthcare services already available through Nepal’s public health system.
Key points about usual care:
It does not include the additional training for Community Health Workers (CHWs) in multimorbidity management.
There are no enhanced home visits, structured symptom monitoring, or peer-supported lifestyle interventions provided through the study.
Patients will access existing services for their chronic conditions as they normally would, without the integrated, co-designed support of the CIMM-CHW model.
So the control treatment is the standard, routine care for hypertension, diabetes, and COPD in the local setting, without the added intervention elements.
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of participants achieving a minimum 5% improvement in at least two chronic disease parameters (HbA1c, systolic blood pressure (SBP), or COPD symptoms)
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Assessment method [1]
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Outcome will assess changes in at least two of the measures of HbA1c, systolic blood pressure (SBP) and COPD symptoms HbA1c-Measured by laboratory serum assay. SBP-Measured using digital sphygmomanometer, averaged over two readings COPD symptoms: measured using the validated COPD Assessment Test (CAT score)
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Timepoint [1]
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Baseline, 6 months, 12 months, and 18 months after randomisation (primary timepoint: 18 months).
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Primary outcome [2]
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Intervention fidelity — degree to which the CIMM-CHW intervention is delivered as intended.
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Assessment method [2]
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Continuous monitoring throughout implementation; formally assessed at 6, 12, and 18 months (primary timepoint: 18 months). Implementation Fedality tool Structured observations, CHW activity logs, and supervisor checklists guided by the Framework for Implementation Fidelity.
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Timepoint [2]
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Baseline, 6 months, 12 months, and 18 months after randomisation (primary timepoint: 18 months).
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Secondary outcome [1]
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Change in Body Mass Index (BMI)
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Assessment method [1]
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Height and weight measured using stadiometer and calibrated scale; BMI calculated as weight (kg)/height (m²)
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Timepoint [1]
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [2]
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Change in quality of life score
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Assessment method [2]
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EQ-5D-5L questionnaire (validated instrument)
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Timepoint [2]
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [3]
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Change in chronic disease self-management practices
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Assessment method [3]
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Self-Management Practices Questionnaire (validated for chronic disease)
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Timepoint [3]
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [4]
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Changes in smoking behaviors
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Assessment method [4]
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Using WHO Steps tool component
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Timepoint [4]
449878
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [5]
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Nutrition behavior
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Assessment method [5]
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Using 24 Hours Diet Recall Survey
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Timepoint [5]
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [6]
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Alcohol behavior
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Assessment method [6]
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AUDIT Alcohol Screening Tool
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Timepoint [6]
450626
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [7]
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Physical activity
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Assessment method [7]
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Physical activity Quentainaire (IPAQ – Short form)
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Timepoint [7]
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Secondary outcome [8]
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Depression
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Assessment method [8]
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Patient health questionnaire-9
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Timepoint [8]
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Baseline, 6 months, 12 months, and 18 months after randomisation
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Eligibility
Key inclusion criteria
Participants are adults aged 30 to 70 years with multimorbidity — so the lower limit is 30.
participants clinically diagnosed two or more chronic conditions.
The protocol does not restrict by sex and aims to include adults from disadvantaged communities regardless of gender.
The study targets adults with two or more chronic conditions — so healthy volunteers are not eligible.
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Minimum age
30
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Individuals physically or cognitively incapable of participating in intervention activities due to severe illness or functional limitations.
People who do not have at least two clinically diagnosed chronic conditions (hypertension, diabetes, COPD).
Individuals under 30 years or over 70 years of age.
People who cannot provide informed consent due to significant cognitive impairment.
Anyone with an acute medical condition requiring hospitalisation at enrolment.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer (or adapt to match your method — e.g., “Allocation concealment will be ensured using stratified randomisation and REDCAP, with allocation performed centrally.”)
This matches what the protocol describes — stratified randomisation using REDCAP to minimise contamination.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation with stratified randomisation: Randomisation list generated by computer, stratified by health facility clusters to reduce contamination between intervention and control groups.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size was calculated to detect a 5% improvement in at least two chronic disease parameters (HbA1c, SBP, CAT score) with 80% power and 95% confidence, assuming an ICC of 0.01 and 10% attrition. Primary outcomes will be analysed using generalised linear mixed models adjusting for clustering, with an intention-to-treat approach. Secondary analyses will include cost-effectiveness and subgroup analysis by age and sex.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/10/2026
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Actual
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Date of last participant enrolment
Anticipated
28/02/2027
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Actual
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Date of last data collection
Anticipated
29/12/2029
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Actual
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Sample size
Target
614
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
27233
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Nepal
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State/province [1]
27233
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Morang and Sunsari districts, Koshi Province
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC), Australia
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
NHMRC
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321964
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Country [1]
321964
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
318047
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Ethical Review, Monitoring and Evaluation Section, Nepal Health Research Council, Government of Nepal, Ram Shah Path Kathmandu, Nepal
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Ethics committee address [1]
318047
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Nepal Health Research Council, Ramshah Path, Kathmandu, Nepal P.O.Box 7626
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Ethics committee country [1]
318047
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Nepal
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Date submitted for ethics approval [1]
318047
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29/08/2025
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Approval date [1]
318047
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Ethics approval number [1]
318047
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Ethics committee name [2]
318051
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Australian National University Human Research Ethics Committee
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Ethics committee address [2]
318051
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https://services.anu.edu.au/research-support/ethics-integrity
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Ethics committee country [2]
318051
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Australia
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Date submitted for ethics approval [2]
318051
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29/08/2025
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Approval date [2]
318051
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Ethics approval number [2]
318051
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Summary
Brief summary
This study aims to test whether a new, co-designed program delivered by Community Health Workers (CHWs) can help adults in eastern Nepal who live with multiple long-term conditions such as high blood pressure, diabetes, and chronic lung disease. Local health workers will be trained to provide home visits, health education, symptom monitoring, and support for healthy living. The study will compare this approach to usual care to see if it improves people’s health and self-management skills. The trial also looks at how well this program can be put into practice in real-world communities.
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Trial website
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Trial related presentations / publications
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Public notes
This trial is part of the Global Alliance for Chronic Diseases Multimorbidity Call, with collaboration from ANU, UNSW, BPKIHS, CRPIN, Miami University , Washington State University and the Ministry of Health Nepal.
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Contacts
Principal investigator
Name
142954
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Dr Uday N. Yadav
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Address
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National Centre for Epidemiology and Population Health, The Australian National University, Canberra ACT 2600
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Country
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Australia
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Phone
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+610405846602
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Fax
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Email
142954
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[email protected]
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Contact person for public queries
Name
142955
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Uday N. Yadav
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Address
142955
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National Centre for Epidemiology and Population Health, The Australian National University, Canberra ACT 2600
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Country
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Australia
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Phone
142955
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+610405846602
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Fax
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Email
142955
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[email protected]
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Contact person for scientific queries
Name
142956
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Uday N. Yadav
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Address
142956
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National Centre for Epidemiology and Population Health, The Australian National University, Canberra ACT 2600
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Country
142956
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Australia
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Phone
142956
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+610405846602
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Fax
142956
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Email
142956
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
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Any type of analysis (i.e. no restrictions on data re-use)
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Systematic reviews and meta-analyses
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Studies exploring new research questions
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Health economic analyses
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Studies testing whether findings can be repeated or confirmed
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Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
•
Via ANU Research Services Division (
[email protected]
). Data sharing agreement required.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
[email protected]
Available via email request
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.
Download to PDF