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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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17 May 2016 |
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Main ID: |
NCT02429297 |
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Date of registration:
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04/03/2015 |
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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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Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia
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Scientific title:
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Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02429297 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Bolivia
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Contacts
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Name:
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John D Piette, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 21-80 years of age
- Diagnosis of hypertension, a systolic blood pressure > 140mmHg, and/or diagnosis of
diabetes
- Access to a functional cell phone
- Able to respond to automated telephone calls
Exclusion Criteria:
- Life-threatening health problem such as cancer with less than a six month life
expectancy
- Are visiting the clinic for an urgent health problem (for themselves)
- If they have severe mental illness as reported by their clinical team
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Diabetes
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Intervention(s)
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Other: HITCM+CP
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Other: HITCM-only
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Primary Outcome(s)
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Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)
[Time Frame: Up to 16 weeks]
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Secondary Outcome(s)
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Patient satisfaction (satisfaction questionnaire)
[Time Frame: Up to 16 weeks]
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Evaluate program feasibility (questionnaire, satisfaction, and usage rates)
[Time Frame: Up to 16 weeks]
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Secondary ID(s)
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HUM00081734
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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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