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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Co-creation (2016 to 2019) + Co-design (2023 to 2024)
BehavioralIt 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)
BehavioralThe 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
Trial outcomes
Primary outcomes
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
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)
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
Secondary outcomes
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
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)
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
Economic evaluation 2
Cost of services provided
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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