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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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16 December 2017 |
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Main ID: |
NCT02758275 |
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Date of registration:
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27/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2
ENURSIN |
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Scientific title:
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Efficacy of Nursing Intervention "Teaching: Individual" to Increase Adherence to Therapeutic Regimen in People With Hypertension Arterial and/or Diabetes Mellitus Type 2 |
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Date of first enrolment:
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April 28, 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02758275 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Sandra Lucrecia SL Romero Guevara, MSc Nursing |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Industrial de Santander |
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Name:
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Dora Inés DI Parra, MSc Nursing |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Industrial de Santander |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult population = 18 years old
- Medical diagnosis of hypertension arterial and/or diabetes mellitus type 2.
- Attendees cardiovascular risk programs of Empresa Social del Estado Instituto de Salud
de Bucaramanga (ISABU)
- People totally independent of their care.
- Access to a fixed telephone line or mobile itself
- Be residents of Bucaramanga
Exclusion Criteria:
- Changes in the mental sphere. Abbreviated Mental Test (Minimental) and Yesavage
depression test.
- Communication limitations or chronic or serious alterations that make it hard
compression of interventions.
- Subjects who are participating in a research study currently or during the last six
months.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Hypertension
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Intervention(s)
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Behavioral: Teaching: Individual (5606)
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Primary Outcome(s)
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Changes of mean score adherence to treatment from baseline at 6 and 12 months
[Time Frame: 6 and 12 months]
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Secondary Outcome(s)
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Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months
[Time Frame: 6 and 12 months]
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Changes of mean systolic blood pressure from baseline at 6 and 12 months
[Time Frame: 6 and 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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