Treat Arterial Hypertension and Diabetes in Rural Africa

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of three different interventions to improve treatment adherence among patients with arterial hypertension or diabetes in rural Cameroon.

Detailed Description
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Non communicable chronic diseases such as arterial hypertension (AH) and diabetes (DM) are a great burden for public health in Cameroon. However, outside the main cities access to appropriate diagnosis and treatment of these health-conditions is still very poor. The Swiss NGO Fondation Coopération Afrique started in 2007 a program to integrate chronic disease management with focus on AH and DM into the primary health care system of peripheral non-physician health facilities in a rural area of Central Cameroon. A first evaluation after one year revealed very low treatment adherence among the newly diagnosed patients as the main challenge. In order to improve patient's adherence we expose them randomly to one of three interventions: The first intervention consists in a written agreement on long-lasting therapy (treatment contract). Patients get information about the importance of a regular long term treatment and personal engagement to follow treatment and clinical controls regularly. The second intervention introduces in addition to the treatment contract a reminder system. In case of follow-up failure a community worker traces the patient to recall the visit at the health centre. The third intervention consists of the treatment contract combined with a financial incentive in form of one month free treatment after four months of regular follow-up. We allocated randomly one of the three interventions to each health center.

Official Title
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A Prospective Randomised Trial Comparing Three Interventions to Improve Treatment Adherence Among Patients With Arterial Hypertension or Diabetes in Rural Cameroon (TAHADIRA-trial 1)

Conditions
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Diabetes, Arterial Hypertension

Intervention / Treatment
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* Other: Treatment contract
* Other: Tracing and recall at home by a community worker
* Other: Incentive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed arterial hypertension or non insulin dependent diabetes type 2 which require treatment and can be treated in the health centre Informed consent by the patient Exclusion Criteria: Patient already under treatment Patients who need to be referred to a hospital No informed consent by the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Other: Treatment contract<br>* Patients signs in for a agreement - to respect a regular follow-up at the health facility.<br>|
| Active Comparator: 2<br> | Other: Treatment contract<br>* Patients signs in for a agreement - to respect a regular follow-up at the health facility.<br>Other: Tracing and recall at home by a community worker<br>* The local health committee sends out a member to trace the patient and to motivate him to take up again regular treatment visits.<br>|
| Active Comparator: 3<br> | Other: Treatment contract<br>* Patients signs in for a agreement - to respect a regular follow-up at the health facility.<br>Other: Incentive<br>* Incentive by giving free treatment after a 4-month regular follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with regular follow-up one year after the treatment was started |  | One patient year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of missed control-visits |  | One patient year | 
| Treatment response of diabetic patients (fasting blood glucose) |  | One patient year | 
| Treatment response of patients with arterial hypertension (blood pressure) |  | One patient year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health care in rural Africa, Chronic non-communicable diseases, Patient Compliance, Treatment adherence