Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449521
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-25
Brief Title:
BECOME COmbined Intervention for MH NCD Delivered by Community Health Workers in Nepal
Sponsor:
Possible
Organization:
Possible
Study Overview
Official Title:
A Type II Hybrid Implementation-effectiveness Study of BECOME BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases Delivered by Community Health Workers in Nepal
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BECOME
Brief Summary:
Common mental health disorders CMDs and noncommunicable diseases NCDs pose significant public health challenges especially in resource-limited settings like Nepal The coexistence of CMDs and NCDs is prevalent tied together by shared behavioral risk factors including stress isolation tobacco use low physical activity poor diet and treatment non-adherence Addressing these risk factors through behavioral interventions has the potential to positively impact both CMDs and NCDs While the World Health Organization WHO recommends three behavioral interventions-evidence-based stress reduction EBSR for stress and anxiety behavioral activation BA for depression and motivational interviewing MI for healthy behaviors-availability remains scarce in low-resource settings
This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases BECOME in Nepal BECOME delivered by community health workers CHWs integrates EBSR BA and MI to improve mental health and address NCDs The study employs a stepped-wedge cluster randomized trial with 20 clusters randomly assigned to five steps starting in the control condition Transitioning every three months clusters gradually adopt the intervention minimizing logistical challenges during implementation
The study targets 600 patient participants age 40 years and above with at least one CMD and NCD from Bardibas and Chandragiri municipalities involving 20 CHWs five primary care providers PCPs and six health system leaders CHWs identify potential participants with research staff assessing eligibility obtaining informed consent and conducting baseline assessments using a digital REDCap tool CHWs undergo BECOME intervention training delivering it to consenting patient participants 30 per CHW Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs Additionally qualitative components following the Reach Effectiveness-Adoption Implementation and Maintenance RE-AIM framework include focus group discussions FGDs with CHWs and Key Informant Interviews KIIs with patient participants PCPs and health system leaders to assess implementation mechanisms outcomes and clinical impact
The study if successful aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs
This research proposes a hybrid implementation-effectiveness study of the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases BECOME in Nepal BECOME delivered by community health workers CHWs integrates EBSR BA and MI to improve mental health and address NCDs The study employs a stepped-wedge cluster randomized trial with 20 clusters randomly assigned to five steps starting in the control condition Transitioning every three months clusters gradually adopt the intervention minimizing logistical challenges during implementation
The study targets 600 patient participants age 40 years and above with at least one CMD and NCD from Bardibas and Chandragiri municipalities involving 20 CHWs five primary care providers PCPs and six health system leaders CHWs identify potential participants with research staff assessing eligibility obtaining informed consent and conducting baseline assessments using a digital REDCap tool CHWs undergo BECOME intervention training delivering it to consenting patient participants 30 per CHW Quantitative data collected quarterly over 12 months will measure primary outcomes for CMDs and NCDs Additionally qualitative components following the Reach Effectiveness-Adoption Implementation and Maintenance RE-AIM framework include focus group discussions FGDs with CHWs and Key Informant Interviews KIIs with patient participants PCPs and health system leaders to assess implementation mechanisms outcomes and clinical impact
The study if successful aims to furnish evidence and a model for implementing behavioral interventions addressing CMDs and NCDs
Detailed Description:
General Objective
To evaluate the effectiveness and implementation of a program called BECOME on depression andor anxiety and two NCDs using a stepped-wedge cluster randomized trial SWCRT and the RE-AIM framework
Specific Objective
1 Assess the effectiveness of BECOME on depression and anxiety and two NCDs diabetes and hypertension via a stepped-wedge cluster randomized trial
2 Assess implementation outcomes of BECOME using the RE-AIM framework at the patient provider and health system levels
3 Conduct a comprehensive costing analysis to provide strategic inputs to support long-term scale up of BECOME
Study Variables Dependent variable Primary outcome depression and anxiety severity Secondary outcome Diabetes as measured by fasting plasma glucose and hypertension as measured by systolic and diastolic blood pressure Independent variable Demographics for example age sex Stress Isolation and withdrawal Quality of Life Tobacco Use Diet Quality Physical activity Medication and follow up adherence Environmental factors- access to care community-based and higher intensity clinical care social support life style
Research Method mixed
Study sites Bardibas and Chandragiri municipalities Nepal
Specify type of Study This study is a type-II hybrid effectiveness- implementation study The study will use a stepped-wedge randomized controlled trial design
Study Population
Patient Participants Individuals who are 40 years or above residing in Chandragiri and Bardibas Municipalities who have at least one NCD hypertension andor diabetes and one Mental Health depression andor anxiety and who give consent for the study participation
Community health workers Community health workers who are working in Chandragiri and Bardibas municipalities under the government pilot program following community health program guidelines 2078 endorsed by the Ministry of Health and Population They are the community health nurses employed by municipalities They are the trusted local member of the community who are trained and regularly supported and monitored by their supervisors They work full-time and get a monthly salary for their servicework
Primary care providers and health system leaders who are working either in the health facilities of Chandragiri and Bardibas municipalities municipal health office and relevant stakeholders who are contributing to the community health program in different capacities
Sampling unit
Since this is a stepped wedge cluster randomized controlled trial we will use the cluster as our sampling unit while implementing the study
Sample size
631 Participants 20 CHWs 5 Primary care providers 6 Health system leaders
Description of study design
The is a type-II hybrid effectiveness-implementation study design The goal of the effectiveness aim is to evaluate the impact of the BECOME intervention against usual care while the implementation aim focuses on understanding the process of implementing the intervention in a real-world setting Additionally the study will conduct a comprehensive costing analysis to provide strategic inputs to support the long-term scale-up of BECOME
The study will use a stepped-wedge cluster randomized controlled trial design In this design 20 clusters wards will be randomly assigned to one of five steps with all clusters starting in the control phase prior to receiving the intervention Every three months four clusters will transition to the intervention condition while the remaining clusters will remain in the control condition This design allows for a gradual rollout of the intervention which can help minimize the impact of any learning curves or logistical challenges that may arise during implementation
The study will use an open cohort design which means that enrollment will be kept open while the intervention is being offered This approach helps to reflect real-world conditions and can compensate for attrition and for participants who may no longer meet the eligibility criteria when their cluster transitions to the treatment phase By using this design the study can capture the dynamic nature of the intervention and better understand its impact over time
Overall this study aims to evaluate the effectiveness and implementation of the BECOME intervention as well as provide insights into the costs associated with implementing the intervention in a real-world setting By using a stepped-wedge cluster randomized controlled trial design and an open cohort design the study can capture a comprehensive picture of the interventions impact and implementation process
To evaluate the effectiveness and implementation of a program called BECOME on depression andor anxiety and two NCDs using a stepped-wedge cluster randomized trial SWCRT and the RE-AIM framework
Specific Objective
1 Assess the effectiveness of BECOME on depression and anxiety and two NCDs diabetes and hypertension via a stepped-wedge cluster randomized trial
2 Assess implementation outcomes of BECOME using the RE-AIM framework at the patient provider and health system levels
3 Conduct a comprehensive costing analysis to provide strategic inputs to support long-term scale up of BECOME
Study Variables Dependent variable Primary outcome depression and anxiety severity Secondary outcome Diabetes as measured by fasting plasma glucose and hypertension as measured by systolic and diastolic blood pressure Independent variable Demographics for example age sex Stress Isolation and withdrawal Quality of Life Tobacco Use Diet Quality Physical activity Medication and follow up adherence Environmental factors- access to care community-based and higher intensity clinical care social support life style
Research Method mixed
Study sites Bardibas and Chandragiri municipalities Nepal
Specify type of Study This study is a type-II hybrid effectiveness- implementation study The study will use a stepped-wedge randomized controlled trial design
Study Population
Patient Participants Individuals who are 40 years or above residing in Chandragiri and Bardibas Municipalities who have at least one NCD hypertension andor diabetes and one Mental Health depression andor anxiety and who give consent for the study participation
Community health workers Community health workers who are working in Chandragiri and Bardibas municipalities under the government pilot program following community health program guidelines 2078 endorsed by the Ministry of Health and Population They are the community health nurses employed by municipalities They are the trusted local member of the community who are trained and regularly supported and monitored by their supervisors They work full-time and get a monthly salary for their servicework
Primary care providers and health system leaders who are working either in the health facilities of Chandragiri and Bardibas municipalities municipal health office and relevant stakeholders who are contributing to the community health program in different capacities
Sampling unit
Since this is a stepped wedge cluster randomized controlled trial we will use the cluster as our sampling unit while implementing the study
Sample size
631 Participants 20 CHWs 5 Primary care providers 6 Health system leaders
Description of study design
The is a type-II hybrid effectiveness-implementation study design The goal of the effectiveness aim is to evaluate the impact of the BECOME intervention against usual care while the implementation aim focuses on understanding the process of implementing the intervention in a real-world setting Additionally the study will conduct a comprehensive costing analysis to provide strategic inputs to support the long-term scale-up of BECOME
The study will use a stepped-wedge cluster randomized controlled trial design In this design 20 clusters wards will be randomly assigned to one of five steps with all clusters starting in the control phase prior to receiving the intervention Every three months four clusters will transition to the intervention condition while the remaining clusters will remain in the control condition This design allows for a gradual rollout of the intervention which can help minimize the impact of any learning curves or logistical challenges that may arise during implementation
The study will use an open cohort design which means that enrollment will be kept open while the intervention is being offered This approach helps to reflect real-world conditions and can compensate for attrition and for participants who may no longer meet the eligibility criteria when their cluster transitions to the treatment phase By using this design the study can capture the dynamic nature of the intervention and better understand its impact over time
Overall this study aims to evaluate the effectiveness and implementation of the BECOME intervention as well as provide insights into the costs associated with implementing the intervention in a real-world setting By using a stepped-wedge cluster randomized controlled trial design and an open cohort design the study can capture a comprehensive picture of the interventions impact and implementation process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH133231-01 | NIH | None | httpsreporternihgovquickSearch1R01MH133231-01 |