DiabetesTAHADIRANCT00744458
Treat Arterial Hypertension and Diabetes in Rural Africa
A study testing Treatment contract, Tracing and recall at home by a community worker and Incentive in people with Diabetes and Arterial Hypertension, run by Cooperation Afrique at 1 site in Cameroon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Arterial Hypertension
- What is being tested?
- Treatment contract, Tracing and recall at home by a community worker and Incentive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteCameroon
- Study dates
- Aug 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient already under treatment
- Patients who need to be referred to a hospital
- No informed consent by the patient
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Medical districts of Mfou, Mbankomo Obala and Esse in Central Cameroon
Divisions of Mefou and Lékié, Central Province, 4056
About this study
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)
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.
Read the 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.
- Conditions
- Diabetes, Arterial Hypertension
- Being tested
- Treatment contract, Tracing and recall at home by a community worker, Incentive
- Keywords
- Primary Health care in rural Africa, Chronic non-communicable diseases, Patient Compliance, Treatment adherence
- Medical subject headings
- Diabetes Mellitus, Hypertension, Noncommunicable Diseases, Patient Compliance, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment contractOther
Patients signs in for a agreement - to respect a regular follow-up at the health facility.
Tracing and recall at home by a community workerOther
The local health committee sends out a member to trace the patient and to motivate him to take up again regular treatment visits.
IncentiveOther
Incentive by giving free treatment after a 4-month regular follow-up
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Other: Treatment contract |
| 2 | Active comparator | Not described Receives: Other: Treatment contract; Other: Tracing and recall at home by a community worker |
| 3 | Active comparator | Not described Receives: Other: Treatment contract; Other: Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with regular follow-up one year after the treatment was started
Measured: One patient year
Secondary outcomes (3)
Percentage of missed control-visits
Measured: One patient year
Treatment response of diabetic patients (fasting blood glucose)
Measured: One patient year
Treatment response of patients with arterial hypertension (blood pressure)
Measured: One patient year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperation Afrique
- Sponsor type
- University, hospital or other
- Investigators
- Engelbert Manga, MD, MPH, Study director, Medical district officer of Mfou, Ministry of public health of CameroonNiklaus D Labhardt, MD, Principal investigator, Representant of the foundation Coopération Afrique, SwitzerlandBeat Stoll, MD, MPH, Study chair, Institute of social and preventive medicine, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744458
- Sponsor's protocol ID
- TAHADIRA
- Acronym
- TAHADIRA
- Status last verified
- Aug 2009
- First submitted
- 29 Aug 2008
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00744458
- Acronym / sponsor ID
- TAHADIRA / TAHADIRA
- Conditions
- Diabetes, Arterial Hypertension
- Keywords
- Primary Health care in rural Africa, Chronic non-communicable diseases, Patient Compliance, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Cooperation AfriqueUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Treatment contract |
| 2 | Active comparator | Other: Treatment contract, Other: Tracing and recall at home by a community worker |
| 3 | Active comparator | Other: Treatment contract, Other: Incentive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient already under treatment
- Patients who need to be referred to a hospital
- No informed consent by the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment contractPatients signs in for a agreement - to respect a regular follow-up at the health facility. | Other | 1, 2, 3 |
| Tracing and recall at home by a community workerThe local health committee sends out a member to trace the patient and to motivate him to take up again regular treatment visits. | Other | 2 |
| IncentiveIncentive by giving free treatment after a 4-month regular follow-up | Other | 3 |
Primary outcome
Percentage of patients with regular follow-up one year after the treatment was started
Time frame: One patient year
3 secondary outcomes
Percentage of missed control-visits
Time frame: One patient year
Treatment response of diabetic patients (fasting blood glucose)
Time frame: One patient year
Treatment response of patients with arterial hypertension (blood pressure)
Time frame: One patient year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engelbert Manga, MD, MPH study director
Medical district officer of Mfou, Ministry of public health of Cameroon
Niklaus D Labhardt, MD principal investigator
Representant of the foundation Coopération Afrique, Switzerland
Beat Stoll, MD, MPH study chair
Institute of social and preventive medicine, University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment contract, Tracing and recall at home by a community worker and Incentive in people with Diabetes and Arterial Hypertension, run by Cooperation Afrique at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with regular follow-up one year after the treatment was started (time frame: One patient year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.