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)

Sponsors

Lead Sponsor: Cooperation Afrique

Source 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.

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.

Overall Status Completed
Start Date August 2008
Completion Date February 2010
Primary Completion Date February 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of patients with regular follow-up one year after the treatment was started One patient year
Secondary Outcome
Measure Time Frame
Percentage of missed control-visits One patient year
Treatment response of diabetic patients (fasting blood glucose) One patient year
Treatment response of patients with arterial hypertension (blood pressure) One patient year
Enrollment 223
Condition
Intervention

Intervention Type: Other

Intervention Name: Treatment contract

Description: Patients signs in for a agreement - to respect a regular follow-up at the health facility.

Intervention Type: Other

Intervention Name: Tracing and recall at home by a community worker

Description: The local health committee sends out a member to trace the patient and to motivate him to take up again regular treatment visits.

Arm Group Label: 2

Intervention Type: Other

Intervention Name: Incentive

Description: Incentive by giving free treatment after a 4-month regular follow-up

Arm Group Label: 3

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon
Location Countries

Cameroon

Verification Date

August 2009

Responsible Party

Name Title: Niklaus Labhardt

Organization: Cooperation Afrique

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 1

Type: Active Comparator

Label: 2

Type: Active Comparator

Label: 3

Type: Active Comparator

Acronym TAHADIRA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov