Implementation of the COmmunity HEalth System InnovatiON Project in Low- and Middle- Income Countries

NCT06989502 | Not Yet Recruiting

• 1 other identifier: NIHR150261
• Study Type: interventional
• Target: 2,094
• Locations: 3 countries
• Sites: 3

Brief Summary

The COHESION-I project will evaluate the effects of the co-creation intervention (2016 to 2019) and the co-design intervention (2023 to 2024) on improving (a) health system responsiveness, and (b) patient satisfaction, at the primary health care level, in Peru, Nepal and Mozambique, in relation to chronic diseases (hypertension, and diabetes mellitus), as well as specific neglected tropical diseases. Each intervention has been tailored to the context and characteristics of each one of the aforementioned low- and middle-income countries. For this quasi-experimental study, three arms were established: the co-creation (2016 to 2019) + co-design (2023 to 2024) arm; the co-design only (2023 to 2024) arm; and the control group (no intervention; usual care). The evaluation will be composed of four types of evaluations: quantitative; qualitative; economic; and process evaluation

Conditions

Hypertension; Diabetes Mellitus; Neglected Tropical Diseases

Keywords

Hypertension; Diabetes Mellitus; Neglected Tropical Diseases; Chronic Disease; Primary Health Care; Implementation Science; Low and Middle Income Countries

Outcome Measures

Primary Outcomes (3)

• Patient Satisfaction (PS)

  Score derived from the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which has been adapted in the local languages of Peru, Nepal, and Mozambique, from its original source in English. The questionnaire consists of 18 items, with classic Likert scale format (5 alternatives). The number of dimensions of Patient Satisfaction could vary by country, as literature demonstrates

  Month 1 (baseline), Month 5 (pre-intervention), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention), Month 21 (follow-up)

• Health System Responsiveness (HSR)

  Score derived from the World Health Organization Health System Responsiveness World Survey, including five -of the eight established- dimensions: autonomy, dignity, clear communication, choice of healthcare provider, and confidentiality. The questionnaire has been adapted in the local languages of Peru, Nepal, and Mozambique, from its original source in English; and it consists of 18 items, with diverse response alternatives (e.g. frequency, "yes or no", amongst other formats)

  Month 1 (baseline), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention)

• Quality of Life (QoL)

  Score derived from the 5-level EQ-5D version questionnaire (EQ-5D-5L), which consists of 2 components. The first one is the EQ-5D descriptive system, which comprises five theoretical dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The second component is the EQ visual analogue scale (EQ VAS), which records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' (score = 100), and 'The worst health you can image' (score = 0). The EQ-5D-5L official translations for Spanish, Nepali, and Portuguese will be used

  Month 1 (baseline), Month 9 (pre-intervention), Month 21 (follow-up)

Secondary Outcomes (9)

• Quantitative evaluation

  Month 1 (baseline), Month 5 (pre-intervention), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention), Month 21 (follow-up)

• Qualitative evaluation

  Month 1 (baseline), Month 8 (pre-intervention), Month 14 (during intervention), Month 20 (post-intervention)

• Economic evaluation 1

  Month 5 (pre-intervention), Month 21 (follow-up)

• Economic evaluation 2

  Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention), Month 21 (follow-up)

• Process evaluation: Context (part 1)

  Month 5 (pre-intervention), Month 21 (follow-up)

Study Arms (3)

Co-creation (2016 to 2019) + Co-design (2023 to 2024)

EXPERIMENTAL

PERU: * Radio programs with content related to health care * Capacity building on management of diabetes, hypertension and neurocysticercosis * Communication jar to prompt communication between health workers and patients * Decentralized decision-making on facility improvement NEPAL: * Radio and pamphlets to promote Primary Health Care (PHC) * Involvement of Female Community Health Volunteers * Capacity building on management of diabetes, hypertension and lepra * Flip charts, guidelines and posters for management of diseases and to prompt communication between health workers and patients * Decentralized decision-making on facility improvement MOZAMBIQUE: * Radio and pamphlets informing population on hypertension, PHC and appointment system * Facility based guideline/algorithm * Capacity building on hypertension, diabetes and schistosomiasis * Establishment of an "information booth" * Group discussions on challenges and opportunities * Advocacy on the issue of access to medicines

Behavioral: Co-creation (2016 to 2019) + Co-design (2023 to 2024)

Co-design only (2023 to 2024)

EXPERIMENTAL

PERU: * Radio programs with content related to health care * Capacity building on management of diabetes, hypertension and neurocysticercosis * Communication jar to prompt communication between health workers and patients * Decentralized decision-making on facility improvement NEPAL: * Radio and pamphlets to promote Primary Health Care (PHC) * Involvement of Female Community Health Volunteers * Capacity building on management of diabetes, hypertension and lepra * Flip charts, guidelines and posters for management of diseases and to prompt communication between health workers and patients * Decentralized decision-making on facility improvement MOZAMBIQUE: * Radio and pamphlets informing population on hypertension, PHC and appointment system * Facility based guideline/algorithm * Capacity building on hypertension, diabetes and schistosomiasis * Establishment of an "information booth" * Group discussions on challenges and opportunities * Advocacy on the issue of access to medicines

Behavioral: Co-design only (2023 to 2024)

Control

NO INTERVENTION

Usual care, understood as the Primary Health Care (PHC) that the target patient population receives as part of the conventional or usual medical practice in each of their communities, in Peru, Nepal, and Mozambique

Interventions

Co-creation (2016 to 2019) + Co-design (2023 to 2024) BEHAVIORAL

It includes interventions implemented in a sequential way: a) The co-creation intervention (between 2016 and 2019), and b) the co-design intervention (between 2023 and 2024). In this group of sequential interventions, relevant stakeholders have already been engaged in the project and they would be familiar with the intervention components. Their participation this time will enable updating and refining the previous co-creation intervention through the co-design process. The intervention will encompass activities with the health service users and healthcare workers, in Peru, Nepal, and Mozambique

Co-creation (2016 to 2019) + Co-design (2023 to 2024)

Co-design only (2023 to 2024) BEHAVIORAL

The same intervention activities of the first group (between 2023 and 2024), but without having them involved in the previous co-creation process. In consequence, relevant stakeholders in the corresponding sites are not expected to be as engaged in the project (in contrast to the intervention that includes co-creation), and they would not be very familiar with the intervention components of COHESION-I. As in the first group, the intervention will encompass activities with the health service users and healthcare workers, in Peru, Nepal, and Mozambique

Co-design only (2023 to 2024)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 years and over, from the selected sites
• Having used the health services in the previous three months
• Diagnosis (or estimated risk) of diabetes mellitus type 2, hypertension, or neurocysticercosis
• Must be able to listen to radio programs, or other audio material
• Males or females aged 18 years and over, from the selected sites
• Having used the health services in the previous three months
• Must be able to listen to radio programs, or other audio material

You may not qualify if:

• \- Diagnosis (or estimated risk) of diabetes mellitus type 2, hypertension, or neurocysticercosis
• The criteria mentioned above refer solely to the quantitative evaluation. For the other types of evaluation, some different populations will be included (such as healthcare workers, local authorities and other stakeholders).

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Eduardo Mondlane University: collaborator
• B.P. Koirala Institute of Health Sciences: collaborator

Study Sites (3)

Eduardo Mondlane University

Maputo, Mozambique

Location

B.P. Koirala Institute of Health Sciences

Dharān, Nepal

Location

Universidad Peruana Cayetano Heredia

Piura, Peru

Location

Related Publications (5)

• Beran D, Lazo-Porras M, Cardenas MK, Chappuis F, Damasceno A, Jha N, Madede T, Lachat S, Perez Leon S, Aya Pastrana N, Pesantes MA, Singh SB, Sharma S, Somerville C, Suggs LS, Miranda JJ. Moving from formative research to co-creation of interventions: insights from a community health system project in Mozambique, Nepal and Peru. BMJ Glob Health. 2018 Nov 16;3(6):e001183. doi: 10.1136/bmjgh-2018-001183. eCollection 2018.

  PMID: 30498592 BACKGROUND

• Pesantes MA, Somerville C, Singh SB, Perez-Leon S, Madede T, Suggs S, Beran D. Disruption, changes, and adaptation: Experiences with chronic conditions in Mozambique, Nepal and Peru. Glob Public Health. 2020 Mar;15(3):372-383. doi: 10.1080/17441692.2019.1668453. Epub 2019 Oct 9.

  PMID: 31596656 BACKGROUND

• Cardenas MK, Perez-Leon S, Singh SB, Madede T, Munguambe S, Govo V, Jha N, Damasceno A, Miranda JJ, Beran D. Forty years after Alma-Ata: primary health-care preparedness for chronic diseases in Mozambique, Nepal and Peru. Glob Health Action. 2021 Jan 1;14(1):1975920. doi: 10.1080/16549716.2021.1975920.

  PMID: 34569443 BACKGROUND

• Bernabe-Ortiz A, Perel P, Miranda JJ, Smeeth L. Diagnostic accuracy of the Finnish Diabetes Risk Score (FINDRISC) for undiagnosed T2DM in Peruvian population. Prim Care Diabetes. 2018 Dec;12(6):517-525. doi: 10.1016/j.pcd.2018.07.015. Epub 2018 Aug 18.

  PMID: 30131300 BACKGROUND

• Lazo-Porras M, Bernabe-Ortiz A, Damasceno A, Sharma SK, Praveen D, Mayo-Puchoc N, Aya Pastrana N, Bazan Maccera M, Chauque A, Cahuana-Hurtado L, Cardenas MK, Gautam U, Khanal VK, Jessen N, Mugabe N, Pereyra R, Pesantes MA, Singh SB, Miranda JJ, Beran D. Implementation of the community health system innovation project in three low- and middle-income countries: COHESION-I study protocol. BMJ Open. 2025 Dec 31;15(12):e109433. doi: 10.1136/bmjopen-2025-109433.

  PMID: 41475833 DERIVED

Related Links

• COHESION-I project description, hosted at the website of CRONICAS Center of Excellence in Chronic Diseases, at Universidad Peruana Cayetano Heredia

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Neglected Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• María Lazo-Porras, MD, MSc, PhD

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Lazo-Porras, MD, MSc, PhD

CONTACT

511-2416978; maria.lazo@upch.pe

Antonio Bernabe-Ortiz, MD, MPH, PhD

CONTACT

antonio.bernabe@upch.pe

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate at CRONICAS

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: May 25, 2025
• Study Start: May 17, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

PE (1); MO (1); NE (1)