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Not yet recruiting NCT06989502

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

No phase Interventional Hypertension Diabetes Mellitus Neglected Tropical Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Co-creation (2016 to 2019) + Co-design (2023 to 2024), Co-design only (2023 to 2024).
Who it may be relevant to
Registry conditions: Hypertension, Diabetes Mellitus, Neglected Tropical Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mozambique, Nepal, Peru
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

GH Project: NIHR150261 - Implementation of the COmmunity HEalth System InnovatiON Project, COHESION-I

Overview

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

Detailed description

The COHESION-I project (I is for Intervention) has two main objectives: first, to implement and evaluate the context specific co-created interventions in the three countries - Mozambique, Nepal, and Peru (Component 1), and second, to explore the possibilities to transfer the experience and lessons learnt to other countries (India) for adaptation of such intervention approach in a different context (Component 2). COHESION-I continues and is based on a previous project called COHESION. The previous project, The COmmunity HEalth System InnovatiON (COHESION) project was a 4-year project that started in 2016 as a collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It enabled formative research to be conducted at policy, health system and community levels using tracer chronic conditions that included non-communicable diseases (NCDs) (diabetes and hypertension), and a specific neglected tropical disease (NTDs) (Schistosomiasis in Mozambique, Leprosy in Nepal and Epilepsy resulting from neurocysticercosis in Peru). The results from this formative research were utilised as part of a process for identifying adequate interventions through a participatory approach with communities, primary healthcare (PHC) workers, and regional health authorities. Meetings with different stakeholders were carried out between 2017 and 2018 to propose context- relevant interventions oriented to address the challenges of providing care for people affected by NCDs and NTDs. During the meetings, participants provided feedback regarding problems and potential solutions for chronic care and health services in general and proposed possible areas of intervention. Upon completion of all the meetings, each country identified the main components to be included in their interventions that were focussed on communities, healthcare workers and facilities. For example, the suggested intervention components in Mozambique include: (i) radio programs, spots, or podcasts and pamphlets to inform population about hypertension, (ii) development of facility-based guideline/algorithm, training in hypertension and clear communication, and group discussions on challenges and opportunities to manage chronic diseases, and (iii) establishment of a medical appointment system for people with chronic diseases.

In this new phase, the COHESION-I project, which will be conducted from 2022 to 2026, the impact of a co-creation/co-design strategy will be evaluated in terms of two main outcomes: on the one hand, improved health system responsiveness at primary care level and patient satisfaction and, on the other hand, improved health care for chronic diseases. The general research objective of COHESION-I is to implement and evaluate at the primary health care level the co-created/co-designed interventions in the selected settings in each of the three countries (Mozambique, Nepal and Peru), focusing on Non-Communicable Diseases (diabetes, hypertension) and Neglected Tropical Diseases (schistosomiasis in Mozambique, Leprosy in Nepal and neurocysticercosis in Peru). This study involves the following evaluation components: quantitative evaluation, qualitative evaluation, economic evaluation, and process evaluation. There will be five trimesters in total for undertaking these different types of evaluations.

This study will implement a mixed-methods approach that includes a pre-post quasi-experimental study: a quantitative component that will accrue an initial survey and five repeated measurements over time with an embedded qualitative study.The study will be developed in three low- and middle-income countries: Mozambique, Nepal and Peru. In each country, the COHESION-I project will be implemented in six sites (A, B, C, D, E and F). From these six sites, two of them have already been selected (A and B sites). The A and B sites are the ones where the co-creation process was conducted between 2016 - 2019, and now, during the current phase, receive the co-designed intervention (co-created + co-designed). Sites C and D have been selected and they have similar characteristics as sites A and B. The difference is that in the previous phase of the COHESION project did not hold any previous activity in these settings. Participants in sites C and D are being engaged for the first time and will receive the same co-designed intervention as sites A and B, but without having been involved in the co-creation process (2016 to 2019). Finally, sites E and F, will share similar characteristics as sites A, B, C, and D, but they will receive no intervention (control sites or usual care).

Interventions

  • Behavioral Co-creation (2016 to 2019) + Co-design (2023 to 2024)
    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 e
  • Behavioral Co-design only (2023 to 2024)
    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 use

Primary outcome measures

  • Patient Satisfaction (PS) [Time frame: 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) [Time frame: Month 1 (baseline), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention)]
  • Quality of Life (QoL) [Time frame: Month 1 (baseline), Month 9 (pre-intervention), Month 21 (follow-up)]
Secondary outcome measures (9)
  • Quantitative evaluation [Time frame: 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 [Time frame: Month 1 (baseline), Month 8 (pre-intervention), Month 14 (during intervention), Month 20 (post-intervention)]
  • Economic evaluation 1 [Time frame: Month 5 (pre-intervention), Month 21 (follow-up)]
  • Economic evaluation 2 [Time frame: Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention), Month 21 (follow-up)]
  • Process evaluation: Context (part 1) [Time frame: Month 5 (pre-intervention), Month 21 (follow-up)]
  • Process evaluation: Context (part 2) [Time frame: Month 5 (pre-intervention), Month 13 (during intervention), Month 21 (follow-up)]
  • Mechanism of Impact [Time frame: Month 5 (pre-intervention), Month 13 (during intervention), Month 21 (follow-up)]
  • Implementation outcomes (part 1) [Time frame: Month 5 (pre-intervention), Month 13 (during intervention), Month 21 (follow-up)]
  • Implementation outcomes (part 2) [Time frame: Month 13 (during intervention)]

Eligibility criteria

Inclusion Criteria for PHC users with diabetes, hypertension, and/or NTDs:

  • 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

Inclusion Criteria for PHC users without diabetes, hypertension, and/or NTDs:

  • 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

Exclusion Criteria for PHC users without diabetes, hypertension, and/or NTDs:

\- 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Mozambique · 1 center
  • Eduardo Mondlane University — Maputo
Nepal · 1 center
  • B.P. Koirala Institute of Health Sciences — Dharān
Peru · 1 center
  • Universidad Peruana Cayetano Heredia — Piura

Publications

  • 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-2018-00 PMID 30498592
  • 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
  • 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
  • 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
  • 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. 2 PMID 41475833

Identifiers

NCT: NCT06989502 · NIHR150261

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗