Clinical trial NCT06163859: Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal
Official title: Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal: An Implementation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Community Health Workers
Hypertension Control
Hypertension Prevention
Implementation Study
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Institute for Implementation Science and Health
First posted: 2023-12-11
Enrollment: 1126
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypertension (HTN) poses a significant global public health challenge, contributing to approximately 13.5% of premature deaths, 54% of incident strokes, and 47% of incident coronary heart disease cases worldwide.(1) In Nepal, HTN prevalence among adults is 25% (2), similar to the global average, but a larger proportion (44%) remain unaware of their condition. (3) To address this issue, Nepal has implemented the Package of Essential Non-Communicable Diseases (PEN) Implementation Plan in line with the Multi-sectoral Action Plan for NCD prevention and control.(4) Studies on the implementation of PEN demonstrate barriers at multiple levels that can not be addressed in just health facility-based service system. In response to multi-level implementation barriers, this study will respond to an urgent need for cost-effective evidence-based HTN control strategies in low-resource settings, particularly reaching the marginalized and disadvantaged population. The study aims to conduct a type III hybrid implementation effectiveness study with two primary objectives. First, it will assess the implementation outcomes of the Female Community Health Volunteers (FCHVs) implementation strategy at various levels using the RE-AIM framework. Secondly, it will examine the effectiveness of the FCHVs strategy compared to facility-based PEN through a pre-post intervention trial, specifically focusing on systolic blood pressure. The study will support Nepal's national NCD priorities. The FCHVs will deliver health education and promotion activities, forming peer groups. Employing a mixed-method approach, the research will employ a cluster randomized controlled trial among 350 participants, collected quantitative data on various implementation dimensions in the intervention arm, supplemented with in-depth interviews and focus group discussions with patients and FCHVs to understand implementation outcomes. Qualitative tracking logs will be maintained to document interactions with FCHVs and healthcare workers. The intervention strategy involves training Female Community Health Volunteers (FCHVs) in health facilities to address hypertension (HTN) in Nepal. The implementation bundle consists of several components: FCHVs will undergo comprehensive training covering mass screening, counseling, medication compliance, self-care, and referrals to healthcare facilities. Mass screening events will be conducted by FCHVs in collaboration with healthcare facility in-charges to identify individuals with hypertension, forming the FCHV-HTN group. Monthly sessions will be held with the FCHV-HTN group, focusing on hypertension discussions, BP log reviews, addressing challenges, and encouraging family involvement. Spouses or adult caretakers will also be invited to promote a supportive environment. FCHVs will have monthly meetings to share experiences, challenges, and refer non-adherent or uncontrolled HTN patients to healthcare facilities with monthly reports and BP logs. This intervention aims to enhance hypertension prevention and management, fostering active community engagement and effective healthcare coordination. The findings of the study will be shared in a comprehensive and inclusive approach, empowering the community with valuable knowledge, fostering evidence-based healthcare practices, and contributing to the advancement of hypertension management strategies in our community and beyond.

Detailed description: Study design: The investigators will conduct a Hybrid type III effectiveness-implementation design focusing primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to the uptake or fidelity of the intervention. A mixed-method approach will be used. The investigators will conduct a cluster randomized controlled trial among 1126 participants, clustered within 12 health facilities. Among the participants of the intervention arm, the investigators will collect quantitative data on adoption, implementation (acceptability, feasibility, cost, fidelity), reach, and maintenance, The investigators will conduct in-depth interviews with 8-16 patients, and 2 FGDs with FCHVs to understand implementation outcomes (acceptability, feasibility, fidelity). The investigators will maintain qualitative tracking logs to document meetings with FCHVs and healthcare workers.

Study site: In partnership with the Ministry of Health and Population (MoHP), the World Health Organization (WHO), and the NCD Flagship Initiative, and with funding from the Norwegian government, Bagmati province has initiated the Hypertension care cascade model in the Kavrepalnchowk district. In this context, our research aims to support the model's objectives by monitoring treatment outcomes and control rates at every stage of care in the Kavre district. The study will involve 12 basic health facilities in Namobuddha municipalities of Kavrepalnchowk, where approximately 82 female community health volunteers (FCHVs) are actively engaged. The selection of the study district and municipalities was done in consultation with WHO Nepal and Nepal Health Research Council, taking into consideration national priorities, Norad priorities, and ongoing NCD care activities in the district.

Study Population: At the facility level, the investigators will include basic health facilities that have implemented PEN, excluding those who are not within the network of the Nepal government health system. At the patient level, inclusion criteria will be: i) 30 years or older ii) have a high blood pressure of 140/90 mmHg, iii) are able to provide informed consent. Exclusion criteria will include: severe illness requiring bed-rest, and pregnant women due to their special health needs

Intervention (implementation strategy): In the intervention group, health facilities will receive training for FCHVs. The FCHVs provide basic health services in Nepal. Since their main role is to promote health and healthy behavior in the community and have contributed tremendously to improving health indicators in Nepal. Their positive roles in the prevention and management of HTN in Nepal have been documented in our pilot studies. The implementation bundle will include:

1. FCHVs training: FCHVs will undergo an extensive training course lasting 4 days. The training will cover various aspects, including screening, counseling, promoting medication compliance and self-care, and referring individuals to healthcare facilities. The development of the training manual drew from valuable resources, such as "Your heart, your life: A CHW's manual for the Hispanic community," with a specific emphasis on incorporating elements of family engagement to effectively identify and address potential issues. Throughout the research process, participants will be actively encouraged to maintain regular follow-up appointments at healthcare facilities. The FCHVs will meticulously review participants' blood pressure (BP) logs and follow established referral protocols to ensure effective management.
2. Mass screening: Each FCHV in collaboration with in-charge of healthcare facilities, will conduct one-day hypertension screening camps in each ward to gather essential information and determine the hypertension status of individuals. This process will generate a comprehensive list of patients with hypertension.
3. Forming a hypertension self-support group, called FCHV-HTN group: FCHVs will form a self-support group of the people (maximum 15 in each group) with hypertension within their catchment area, who are identified through the mass screening or are self-reported.
4. Monthly sessions of FCHV-HTN group: FCHV will conduct a monthly meeting with the FCHV-HTN group. During these monthly sessions, which will last for 60 minutes, FCHVs will engage participants in discussions about hypertension and strategies for control, review participants' BP logs, address ongoing challenges related to hypertension management, and encourage visits to healthcare facilities if necessary. These visits will foster sustained engagement and active involvement of participants and their family members, enabling meaningful discussions about the barriers encountered in implementing action plans and achieving predetermined goals. Furthermore, in each interaction program, the spouse or adult caretaker of the hypertensive participant will be invited to promote a supportive environment at the family and community levels.
5. Referral and linkage to 'Hypertension care cascade model': FCHV meeting with health facility in-charge: FCHV will hold their 45 minutes monthly meeting in the presence of a health facility in charge where she will be sharing her experiences and challenges for hypertension prevention and challenges. This meeting is expected to inform the health facilities and plan their activities accordingly. FCHVs will identify hypertension patients who are non-adherent and/or whose blood pressure is not under control to the health facility, and list and blood pressure log will be submitted monthly to the health facility.

Tools and data collection: At baseline, trained research assistants will collect the following data using face-to-face interview technique: Sociodemographic data (age, gender, marital status, education, occupation, income using validated STEPs survey questionnaire;2 Lifestyle factors (fruits and vegetable intake using diet quality questionnaire19, physical using a global physical activity questionnaire20, alcohol (drinks per week) and smoking (cigarettes per day), knowledge of hypertension21, and medication. (3)Blood pressure will be taken during baseline and end line. The process tracking system will also serve as a monitoring tool to support program implementation. FCHVs will be asked by healthcare workers to complete a monthly checklist to capture completed intervention activities, including records of patients who attended. Study staff will make monthly phone calls to healthcare workers to ensure the collection of these data. At the health facility level, the investigators will use attendance records to measure FCHV's completion of training. The system will also capture costs associated with implementation. The investigators will validate the process tracking measures of implementation against measures collected in the community survey.

Blood pressure will be taken during baseline and endline. The investigators will be using both quantitative and qualitative tools to measure our primary outcomes. The investigators will conduct In-depth interviews (IDIs) and Focus group discussion (FGDs) and transcribe all the discussions and interviews into Nepali. The principal investigators and local principal investigator then independently review the transcripts against the audio recording for potential discrepancies or incomplete data. The investigators will conduct abductive analysis, using first inductive codes (e.g., emerging from the data) and transposing these into deductive CFIR constructs. RAs will keep field notebooks to document observed behaviors of providers and patients relevant to implementation.

For qualitative information collection, the investigators will develop an IDI guide based on previous literature for qualitative study.

Data analysis:

1. The investigators will compute estimates of adoption, implementation, reach and maintenance, with appropriate 95% confidence intervals. Reach is defined as % of FCHVs implementing the program will participate in monthly meetings; at Client level: percent of the hypertensive patients in the community are aware of their high BP status. Adoption is defined as % of the health facilities asked to participate in adopting the program i.e. FCHVs complete the initial training session. Program implementation is defined as % of the health facility will implement a minimum standard to program implementation, measured by: (1) healthcare workers conduct monthly meetings; (2) first home visits by FCHVs to the target clients; and (3) FCHV submit monthly reports. In addition, the investigators will explore facilitators and barriers to implementation. Maintenance is defined as Direct and indirect cost running for program maintenance.
2. For qualitative FGDs and interviews, the investigators will conduct abductive analysis36, using first inductive codes (e.g., emerging from the data) and transposing these into deductive CFIR constructs. RAs will keep field notebooks to document observed behaviors of providers and patients relevant to implementation.37
3. The baseline characteristics will be presented as the mean (standard deviation) or, median (interquartile) for continuous; and frequency (%) for categorical variables. Primary analyses of the outcome, mean systolic BP at 3 months using paired t-test.

The investigators will conduct a mixed-methods assessment of the implementation outcomes by combining data from quantitative tools and from in-depth interviews.

Eligibility criteria: Inclusion Criteria:

* 30 years or older
* have a high blood pressure of 140/90 mmHg or under hypertension medication
* are able to provide informed consent.

Exclusion Criteria:

* severe illness requiring bed rest, and
* pregnant women, due to their special health needs.

Primary outcomes:
measure: Reach
timeFrame: 6 months
measure: Adoption
timeFrame: 6 months
measure: Implementation
timeFrame: 6 months
measure: Mean systolic blood pressure (BP) (mmHg)
timeFrame: 6 months
Secondary outcomes:
measure: Mean diastolic BP (mmHg)
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Fruits and vegetables intake
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Proportion controlling BP (<140/90 mmHg)
timeFrame: 6 months
Other outcomes:
Locations:
city: Kavre
country: Nepal
facility: Institute for Implementation Science and Health
state: Bagmati
Study officials:
References:
citation: Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.
citation: Aryal KK, Mehata S, Neupane S, Vaidya A, Dhimal M, Dhakal P, Rana S, Bhusal CL, Lohani GR, Paulin FH, Garg RM, Guthold R, Cowan M, Riley LM, Karki KB. The Burden and Determinants of Non Communicable Diseases Risk Factors in Nepal: Findings from a Nationwide STEPS Survey. PLoS One. 2015 Aug 5;10(8):e0134834. doi: 10.1371/journal.pone.0134834. eCollection 2015.
citation: Karmacharya BM, Koju RP, LoGerfo JP, Chan KC, Mokdad AH, Shrestha A, Sotoodehnia N, Fitzpatrick AL. Awareness, treatment and control of hypertension in Nepal: findings from the Dhulikhel Heart Study. Heart Asia. 2017 Jan 4;9(1):1-8. doi: 10.1136/heartasia-2016-010766. eCollection 2017.
citation: Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
citation: Svetkey LP, Simons-Morton DG, Proschan MA, Sacks FM, Conlin PR, Harsha D, Moore TJ. Effect of the dietary approaches to stop hypertension diet and reduced sodium intake on blood pressure control. J Clin Hypertens (Greenwich). 2004 Jul;6(7):373-81. doi: 10.1111/j.1524-6175.2004.03523.x.
citation: Parker ED, Schmitz KH, Jacobs DR Jr, Dengel DR, Schreiner PJ. Physical activity in young adults and incident hypertension over 15 years of follow-up: the CARDIA study. Am J Public Health. 2007 Apr;97(4):703-9. doi: 10.2105/AJPH.2004.055889. Epub 2007 Feb 28.
citation: Ascherio A, Hennekens C, Willett WC, Sacks F, Rosner B, Manson J, Witteman J, Stampfer MJ. Prospective study of nutritional factors, blood pressure, and hypertension among US women. Hypertension. 1996 May;27(5):1065-72. doi: 10.1161/01.hyp.27.5.1065.
citation: Zachariah R, Ford N, Philips M, Lynch S, Massaquoi M, Janssens V, Harries AD. Task shifting in HIV/AIDS: opportunities, challenges and proposed actions for sub-Saharan Africa. Trans R Soc Trop Med Hyg. 2009 Jun;103(6):549-58. doi: 10.1016/j.trstmh.2008.09.019. Epub 2008 Nov 6.
citation: Jindal D, Sharma H, Gupta Y, Ajay VS, Roy A, Sharma R, Ali M, Jarhyan P, Gupta P, Srinivasapura Venkateshmurthy N, Ali MK, Narayan KMV, Prabhakaran D, Weber MB, Mohan S, Patel SA, Tandon N. Improving care for hypertension and diabetes in india by addition of clinical decision support system and task shifting in the national NCD program: I-TREC model of care. BMC Health Serv Res. 2022 May 23;22(1):688. doi: 10.1186/s12913-022-08025-y.
citation: Labhardt ND, Balo JR, Ndam M, Grimm JJ, Manga E. Task shifting to non-physician clinicians for integrated management of hypertension and diabetes in rural Cameroon: a programme assessment at two years. BMC Health Serv Res. 2010 Dec 14;10:339. doi: 10.1186/1472-6963-10-339.
citation: Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.
citation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
citation: Neupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, Kallestrup P. Female community health volunteers to reduce blood pressure: feasible and sustainable? - Authors' reply. Lancet Glob Health. 2018 Apr;6(4):e374. doi: 10.1016/S2214-109X(18)30033-0. No abstract available.
citation: Neupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, Kallestrup P. Effectiveness of a lifestyle intervention led by female community health volunteers versus usual care in blood pressure reduction (COBIN): an open-label, cluster-randomised trial. Lancet Glob Health. 2018 Jan;6(1):e66-e73. doi: 10.1016/S2214-109X(17)30411-4.
citation: Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.
citation: Shrestha A, Maharjan R, Karmacharya BM, Bajracharya S, Jha N, Shrestha S, Aryal A, Baral PP, Bhatt RD, Bhattarai S, Bista D, Citrin D, Dhimal M, Fitzpatrick AL, Jha AK, Karmacharya RM, Mali S, Neupane T, Oli N, Pandit R, Parajuli SB, Pradhan PMS, Prajapati D, Pyakurel M, Pyakurel P, Rai BK, Sapkota BP, Sapkota S, Shrestha A, Shrestha AP, Shrestha R, Sharma GN, Sharma S, Spiegelman D, Suwal PS, Thapa B, Vaidya A, Xu D, Yan LL, Koju R. Health system gaps in cardiovascular disease prevention and management in Nepal. BMC Health Serv Res. 2021 Jul 5;21(1):655. doi: 10.1186/s12913-021-06681-0.