HypertensionCOHESION-INCT06989502
Implementation of the COmmunity HEalth System InnovatiON Project in Low- and Middle- Income Countries
A study testing Co-creation (2016 to 2019) + Co-design (2023 to 2024) and Co-design only (2023 to 2024) in people with Hypertension and Diabetes Mellitus, run by Universidad Peruana Cayetano Heredia at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Neglected Tropical Diseases
- What is being tested?
- Co-creation (2016 to 2019) + Co-design (2023 to 2024) and Co-design only (2023 to 2024)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,094 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 17 May 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Antonio Bernabe-Ortiz, MD, MPH, PhD contact
3 sites in 3 countries
Mozambique1 site
Eduardo Mondlane University
Maputo
Albertino Damasceno, MD, PhD
Peru1 site
Universidad Peruana Cayetano Heredia
Piura
María Lazo-Porras, MD, MSc, PhD
Antonio Bernabe-Ortiz, MD, MPH, PhD
About this study
Official title: GH Project: NIHR150261 - Implementation of the COmmunity HEalth System InnovatiON Project, COHESION-I
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
Read the 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).
- Conditions
- Hypertension, Diabetes Mellitus, Neglected Tropical Diseases
- Being tested
- Co-creation (2016 to 2019) + Co-design (2023 to 2024), Co-design only (2023 to 2024)
- Keywords
- Hypertension, Diabetes Mellitus, Neglected Tropical Diseases, Chronic Disease, Primary Health Care, Implementation Science, Low and Middle Income Countries
- Medical subject headings
- Hypertension, Diabetes Mellitus, Neglected Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-creation (2016 to 2019) + Co-design (2023 to 2024)Behavioural
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-design only (2023 to 2024)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: Month 1 (baseline), Month 9 (pre-intervention), Month 21 (follow-up)
Secondary outcomes (9)
Quantitative evaluation
A group of outcomes, incluiding: access to antihypertensive drugs; antihypertensive treatment; blood pressure control; access to antidiabetic drugs; antidiabetic treatment; glycemic control. The evaluation of these outcomes, using quantitative methods, will be carried out through: questionnaires, adapted in the local languages of Peru, Nepal, and Mozambique
Measured: 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
A group of outcomes, incluiding: perceived value of health services; patient satisfaction; perceived roles and responsibilities of healthcare workers; perceived capacity of healthcare workers to deliver services. The evaluation of these outcomes, using qualitative methods, will be carried out through: semi-structured interviews, pictures taken by participants, individual diaries and team meetings (research team reflexivity)
Measured: Month 1 (baseline), Month 8 (pre-intervention), Month 14 (during intervention), Month 20 (post-intervention)
Economic evaluation 1
A group of outcomes, incluiding: cost per satisfied patient; cost per patient with a positive perception of health system's responsiveness; out-of-pocket expenses; cost per QALY gained. The evaluation of these outcomes, using mixed methods, will be carried out through: interviews of key informants, on-site observations, and review of documentation
Measured: Month 5 (pre-intervention), Month 21 (follow-up)
Economic evaluation 2
Cost of services provided
Measured: Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention), Month 21 (follow-up)
Process evaluation: Context (part 1)
Health system-level indicators
Measured: Month 5 (pre-intervention), Month 21 (follow-up)
Process evaluation: Context (part 2)
Barriers and facilitators
Measured: Month 5 (pre-intervention), Month 13 (during intervention), Month 21 (follow-up)
Mechanism of Impact
Coherence, Cognitive Participation, Collective Action and Reflexing Monitoring
Measured: Month 5 (pre-intervention), Month 13 (during intervention), Month 21 (follow-up)
Implementation outcomes (part 1)
Reach and dose of the communication strategy
Measured: Month 5 (pre-intervention), Month 13 (during intervention), Month 21 (follow-up)
Implementation outcomes (part 2)
Acceptability of the training of the HCWs
Measured: Month 13 (during intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start17 May 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,094 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Eduardo Mondlane University, B.P. Koirala Institute of Health Sciences
- Responsible party
- Principal investigator, María Lazo Porras, Universidad Peruana Cayetano Heredia
- Investigators
- María Lazo-Porras, MD, MSc, PhD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989502
- Sponsor's protocol ID
- NIHR150261
- Acronym
- COHESION-I
- Status last verified
- May 2025
- First submitted
- 8 Oct 2024
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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-2018-001183. eCollection 2018.
PubMed 30498592Pesantes 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.
PubMed 31596656Cardenas 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.
PubMed 34569443Bernabe-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.
PubMed 30131300Lazo-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.
PubMed 41475833
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GH Project: NIHR150261 - Implementation of the COmmunity HEalth System InnovatiON Project, COHESION-I
- ClinicalTrials.gov ID
- NCT06989502
- Acronym / sponsor ID
- COHESION-I / NIHR150261
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,094 participants (estimated)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Eduardo Mondlane University, B.P. Koirala Institute of Health Sciences
- Study start
- 17 May 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-creation (2016 to 2019) + Co-design (2023 to 2024) | Experimental | Behavioral: Co-creation (2016 to 2019) + Co-design (2023 to 2024)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 |
| Co-design only (2023 to 2024) | Experimental | Behavioral: Co-design only (2023 to 2024)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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 encompass activities with the health service users and healthcare workers, in Peru, Nepal, and Mozambique | Behavioural | Co-creation (2016 to 2019) + Co-design (2023 to 2024) |
| 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 users and healthcare workers, in Peru, Nepal, and Mozambique | Behavioural | Co-design only (2023 to 2024) |
Primary outcome
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)
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
Health System Responsiveness (HSR)
Time frame: Month 1 (baseline), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention)
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)
Quality of Life (QoL)
Time frame: Month 1 (baseline), Month 9 (pre-intervention), Month 21 (follow-up)
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
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 30498592Beran 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.
- Background: PubMed 31596656Pesantes 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.
- Background: PubMed 34569443Cardenas 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.
- Background: PubMed 30131300Bernabe-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.
- Derived from this study: PubMed 41475833Lazo-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.
- COHESION-I project description, hosted at the website of CRONICAS Center of Excellence in Chronic Diseases, at Universidad Peruana Cayetano HerediaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Bernabe-Ortiz, MD, MPH, PhD contact
María Lazo-Porras, MD, MSc, PhD principal investigator
Universidad Peruana Cayetano Heredia
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-creation (2016 to 2019) + Co-design (2023 to 2024) and Co-design only (2023 to 2024) in people with Hypertension and Diabetes Mellitus, run by Universidad Peruana Cayetano Heredia at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mozambique, Nepal, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Lazo-Porras, MD, MSc, PhD (511-2416978, maria.lazo@upch.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989502, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.