NCT00744458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

August 1, 2009

Enrollment Period

1.5 years

First QC Date

August 29, 2008

Last Update Submit

May 26, 2010

Conditions

DiabetesArterial Hypertension

Keywords

Primary Health care in rural AfricaChronic non-communicable diseasesPatient ComplianceTreatment adherence

Outcome Measures

Primary Outcomes (1)

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

    One patient year

Secondary Outcomes (3)

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR
Other: Treatment contract

2

ACTIVE COMPARATOR
Other: Treatment contractOther: Tracing and recall at home by a community worker

3

ACTIVE COMPARATOR
Other: Treatment contractOther: Incentive

Interventions

Treatment contractOTHER

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

123
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.

2
IncentiveOTHER

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

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient already under treatment
  • Patients who need to be referred to a hospital
  • No informed consent by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionNoncommunicable DiseasesPatient ComplianceTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareHealth BehaviorBehavior

Study Officials

  • Engelbert Manga, MD, MPH

    Medical district officer of Mfou, Ministry of public health of Cameroon

    STUDY DIRECTOR

  • Niklaus D Labhardt, MD

    Representant of the foundation Coopération Afrique, Switzerland

    PRINCIPAL INVESTIGATOR

  • Beat Stoll, MD, MPH

    Institute of social and preventive medicine, University of Geneva, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 27, 2010

Record last verified: 2009-08

Locations

CA(1)