Hypertension Clinical Trial
Official title:
Location-based Tailored Messaging to Reduce Sodium Intake in Hypertensive Patients
Verified date | June 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 26, 2019 |
Est. primary completion date | April 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - > 18 years of age - Hypertension - Use of anti-hypertensive therapy for at least 3 months, with stable anti-hypertensive therapy (medication type and dose) for at least 2 weeks - Daily sodium intake of >2,000 mg with sodium to kcal ratio > 1, estimated via Food Frequency Questionnaire - Ownership and use of an Apple iPhone Exclusion Criteria: - Chronic Kidney Disease - Heart Failure - Systolic Blood Pressure >180 mm Hg - Diastolic Blood Pressure >110 mm Hg - Use of a loop diuretic or corticosteroid - Insulin dependent diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
United States | Michigan Medicine, University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in blood pressure | Change in home-measured brachial cuff blood pressure | Baseline, week 8 | |
Other | Estimated dietary sodium intake | Estimated dietary sodium intake from Block Food Frequency Questionnaire (inter-group comparison at week 8, intra-group change from baseline-week 8) | Baseline, week 8 | |
Primary | 24-hour urinary sodium excretion | Change from baseline in 24-hour urinary sodium excretion at week 8 | Baseline, Week 8 | |
Primary | Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS) | Change from baseline in Self-care Confidence in Following a Low-sodium Diet Scale (SCFLDS) at week 8. It assesses the participants' confidence in the ability to select and prepare low-sodium foods. The self-reported tool consists of 7 items with 4 response options per item. The score range is 1-4 (1=Not confident, 2=Somewhat confident, 3=Very confident, 4=Extremely confident) then added for each question. Possible scores range from 7 to 28 and the higher the score indicates greater confidence. | Baseline, Week 8 |
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