Treat Arterial Hypertension and Diabetes in Rural Africa (TAHADIRA)

May 26, 2010 updated by: Cooperation Afrique

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
    • Central Province
      • Divisions of Mefou and Lékié, Central Province, Cameroon, 4056
        • Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cooperation Afrique

Investigators

  • Study Director: Engelbert Manga, MD, MPH, Medical district officer of Mfou, Ministry of public health of Cameroon
  • Principal Investigator: Niklaus D Labhardt, MD, Representant of the foundation Coopération Afrique, Switzerland
  • Study Chair: Beat Stoll, MD, MPH, Institute of social and preventive medicine, University of Geneva, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAHADIRA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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