Treat Arterial Hypertension and Diabetes in Rural Africa

Diabetes Clinical Trial

— TAHADIRA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744458
• Other study ID #: TAHADIRA
• Status: Completed
• Phase: N/A
• First received: August 29, 2008
• Last updated: May 26, 2010
• Start date: August 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2009
• Source: Cooperation Afrique
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arterial Hypertension
• Diabetes
• Hypertension

Intervention

Other:
• Treatment contract
Patients signs in for a agreement - to respect a regular follow-up at the health facility.
• 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.
• Incentive
Incentive by giving free treatment after a 4-month regular follow-up

Locations

Country	Name	City	State
Cameroon	Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon	Divisions of Mefou and Lékié	Central Province

Sponsors (1)

Lead Sponsor	Collaborator
Cooperation Afrique

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with regular follow-up one year after the treatment was started		One patient year	No
Secondary	Percentage of missed control-visits		One patient year	No
Secondary	Treatment response of diabetic patients (fasting blood glucose)		One patient year	No
Secondary	Treatment response of patients with arterial hypertension (blood pressure)		One patient year	No