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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02032108 |
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Date of registration:
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08/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Lifestyle Education Programs on Diabetes Control in Rwanda
LIDI |
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Scientific title:
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Effects of Lifestyle Education Programs on Diabetes Control Among Diabetic Patients at Kigali University Teaching Hospital Rwanda |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02032108 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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Etienne Amendezo, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kigali University Teaching Hospital |
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Name:
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Charlotte M. Bavuma, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kigali University Teaching Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosis of diabetes known since three months at least,
- being currently on treatment (insulin or oral hypoglycemiants),
- able to follow up at CHUK
Exclusion Criteria:
- patients with advanced diabetic complications (advanced nephropathy & CKD,
proliferative retinopathy, recent history of myocardial infarction & severe Heart
Failure (LVEF<35%), peripheral artery disease, stroke, severe diabetic foot disease,
- any other severe illness that may impede the patient's functional capacity,
- severe psychiatric disorders
- pregnancy
Age minimum:
21 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Behavioral: lifestyle counselling
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Primary Outcome(s)
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between groups difference in glycated haemoglobin (HbA1c)
[Time Frame: 12 months]
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Secondary Outcome(s)
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endpoint versus baseline differences in glycated hemoglobin
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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