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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Peruana Cayetano Heredia

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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-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

Treatment groups

2,094 Participants
are divided into 3 treatment groups
Group A: Co-creation (2016 to 2019) + Co-design (2023 to 2024)Experimental treatment 1 intervention
Group B: Co-design only (2023 to 2024)Experimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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)
2

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)

Time frame
Month 1 (baseline), Month 9 (pre-intervention), Month 13 (during intervention), Month 17 (post-intervention)
3

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

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

Secondary outcomes

1

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

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)
2

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)

Time frame
Month 1 (baseline), Month 8 (pre-intervention), Month 14 (during intervention), Month 20 (post-intervention)
3

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

Time frame
Month 5 (pre-intervention), Month 21 (follow-up)
4

Economic evaluation 2

Cost of services provided

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

Other outcomes

Sponsors and contacts

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Universidad Peruana Cayetano Heredia

Lead sponsor

Eduardo Mondlane University

Collaborator

B.P. Koirala Institute of Health Sciences

Collaborator

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