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
  Purpose

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 Intervention
Diabetes
Arterial Hypertension
Other: Treatment contract
Other: Tracing and recall at home by a community worker
Other: Incentive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Cooperation Afrique:

Primary Outcome Measures:
  • Percentage of patients with regular follow-up one year after the treatment was started [ Time Frame: One patient year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 223
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Niklaus Labhardt, Cooperation Afrique
ClinicalTrials.gov Identifier: NCT00744458     History of Changes
Other Study ID Numbers: TAHADIRA
Study First Received: August 29, 2008
Last Updated: May 26, 2010
Health Authority: Cameroon: Ministry of Public Health

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

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

ClinicalTrials.gov processed this record on September 18, 2014