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Treat Arterial Hypertension and Diabetes in Rural Africa (TAHADIRA)

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ClinicalTrials.gov Identifier: NCT00744458
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
Cooperation Afrique

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.

Condition or disease Intervention/treatment
Diabetes Arterial Hypertension Other: Treatment contract Other: Tracing and recall at home by a community worker Other: Incentive

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  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : August 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Arm Intervention/treatment
Active Comparator: 1 Other: Treatment contract
Patients signs in for a agreement - to respect a regular follow-up at the health facility.
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: 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



Primary Outcome Measures :
  1. Percentage of patients with regular follow-up one year after the treatment was started [ Time Frame: One patient year ]

Secondary Outcome Measures :
  1. Percentage of missed control-visits [ Time Frame: One patient year ]
  2. Treatment response of diabetic patients (fasting blood glucose) [ Time Frame: One patient year ]
  3. Treatment response of patients with arterial hypertension (blood pressure) [ Time Frame: One patient year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744458


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

Responsible Party: Niklaus Labhardt, Cooperation Afrique
ClinicalTrials.gov Identifier: NCT00744458     History of Changes
Other Study ID Numbers: TAHADIRA
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: August 2009

Keywords provided by Cooperation Afrique:
Primary Health care in rural Africa
Chronic non-communicable diseases
Patient Compliance
Treatment adherence

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases