Clinical trial NCT00744458: Treat Arterial Hypertension and Diabetes in Rural Africa
Official title: A Prospective Randomised Trial Comparing Three Interventions to Improve Treatment Adherence Among Patients With Arterial Hypertension or Diabetes in Rural Cameroon (TAHADIRA-trial 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Arterial Hypertension
Keywords: Primary Health care in rural Africa
Chronic non-communicable diseases
Patient Compliance
Treatment adherence
Lead sponsor: Cooperation Afrique
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with regular follow-up one year after the treatment was started
timeFrame: One patient year
Secondary outcomes:
measure: Percentage of missed control-visits
timeFrame: One patient year
measure: Treatment response of diabetic patients (fasting blood glucose)
timeFrame: One patient year
measure: Treatment response of patients with arterial hypertension (blood pressure)
timeFrame: One patient year
Other outcomes:
Locations:
city: Divisions of Mefou and Lékié
country: Cameroon
facility: Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon
state: Central Province
Study officials:
affiliation: Medical district officer of Mfou, Ministry of public health of Cameroon
name: Engelbert Manga, MD, MPH
role: STUDY_DIRECTOR
affiliation: Representant of the foundation Coopération Afrique, Switzerland
name: Niklaus D Labhardt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of social and preventive medicine, University of Geneva, Switzerland
name: Beat Stoll, MD, MPH
role: STUDY_CHAIR
References: