Treat Arterial Hypertension and Diabetes in Rural Africa (TAHADIRA)

This study has been completed.
Sponsor:
Information provided by:
Cooperation Afrique
ClinicalTrials.gov Identifier:
NCT00744458
First received: August 29, 2008
Last updated: May 26, 2010
Last verified: August 2009

August 29, 2008
May 26, 2010
August 2008
February 2010   (final data collection date for primary outcome measure)
Percentage of patients with regular follow-up one year after the treatment was started [ Time Frame: One patient year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00744458 on ClinicalTrials.gov Archive Site
  • Percentage of missed control-visits [ Time Frame: One patient year ] [ Designated as safety issue: No ]
  • Treatment response of diabetic patients (fasting blood glucose) [ Time Frame: One patient year ] [ Designated as safety issue: No ]
  • Treatment response of patients with arterial hypertension (blood pressure) [ Time Frame: One patient year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treat Arterial Hypertension and Diabetes in Rural Africa
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Diabetes
  • Arterial Hypertension
  • 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.
  • Other: Incentive
    Incentive by giving free treatment after a 4-month regular follow-up
  • Active Comparator: 1
    Intervention: Other: Treatment contract
  • Active Comparator: 2
    Interventions:
    • Other: Treatment contract
    • Other: Tracing and recall at home by a community worker
  • Active Comparator: 3
    Interventions:
    • Other: Treatment contract
    • Other: Incentive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
223
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT00744458
TAHADIRA
Yes
Niklaus Labhardt, Cooperation Afrique
Cooperation Afrique
Not Provided
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
Cooperation Afrique
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP