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Completed

NCT Number: NCT00744458

Treat Arterial Hypertension and Diabetes in Rural Africa

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon

Divisions of Mefou and Lékié, Central Province, 4056, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment contract

Other

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

Other

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

Incentive

Other

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

Primary outcomes

  1. Percentage of patients with regular follow-up one year after the treatment was started

    Time frame: One patient year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cooperation Afrique

Other

Registry information

Official study 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)

Acronym: TAHADIRA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 1, 2008
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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