Treat Arterial Hypertension and Diabetes in Rural Africa (TAHADIRA)
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| First Received Date ICMJE | August 29, 2008 | ||||||||||||
| Last Updated Date | May 26, 2010 | ||||||||||||
| Start Date ICMJE | August 2008 | ||||||||||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Percentage of patients with regular follow-up one year after the treatment was started [ Time Frame: One patient year ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00744458 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Treat Arterial Hypertension and Diabetes in Rural Africa | ||||||||||||
| Official Title ICMJE | A Prospective Randomised Trial Comparing Three Interventions to Improve Treatment Adherence Among Patients With Arterial Hypertension or Diabetes in Rural Cameroon (TAHADIRA-trial 1) | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 223 | ||||||||||||
| Completion Date | February 2010 | ||||||||||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Cameroon | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00744458 | ||||||||||||
| Other Study ID Numbers ICMJE | TAHADIRA | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Niklaus Labhardt, Cooperation Afrique | ||||||||||||
| Study Sponsor ICMJE | Cooperation Afrique | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Cooperation Afrique | ||||||||||||
| Verification Date | August 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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