- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00987025
Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers (TEAhM)
Technologies for Enhancing Access and Health Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
TEAhM will be conducted in four senior nutrition centers in the state of Ohio. Using these facilities as field centers, we will recruit 144 older, hypertensive adults who receive nutrition assistance at these centers. Wright State staff will obtain permission from enrolled participants in the intervention centers to contact primary care physicians for the purpose of obtaining recommended intervention protocols and defining referral criteria for changes in blood pressure treatment. We will install telehealth kiosks at two of the four nutrition centers. Participants who enroll at the two centers with kiosks will be considered "intervention participants" and those who enroll at the two centers without the kiosks will be considered "control participants." The kiosks will enable participants to conduct self-monitoring of their blood pressure at the nutrition facility. Blood pressure data from intervention participants will be sent to a central server managed by Healthanywhere, the telehealth partner in this project. Nurse-researchers from WSU will receive email alerts about out of range blood pressure measures, monitor blood pressure readings once a week, and make referrals for medical care according to criteria defined by participants' primary care physicians at the time of enrollment. Control and intervention participants will receive educational materials on general wellness that are publicly available.
Demographic information, background health, comfort with technology, and baseline blood pressure measures will be collected at baseline in on paper forms by WSU nurse researchers. Follow up blood pressure measures and other health utilization measures and reported health events will be collected from both intervention and control facilities during follow-up phone contacts with study personnel every two months. Blood pressure will be measured for all participants at the end of the study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Bellefontaine, Ohio, United States, 43311
- Logan County Friendly Senior Center
-
Miamisburg, Ohio, United States, 45342
- Miamisburg Senior Adult Center
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Spring Valley, Ohio, United States, 45385
- Spring Valley Senior Center
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Urbana, Ohio, United States, 43078
- Urbana-Champaign County Senior Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥55 years
- Current use of nutrition center resources ≥1 time/week
- Physician-diagnosed hypertension
- Clinically stable if on oral therapy
- Physician willingness to interact with nurse reviewers (intervention arm only)
Exclusion Criteria:
- Age < 55 years
- Self-reported dialysis or renal failure
- Cognitive impairment as evaluated by study staff
- Failure to provide consent
- Failure to meet all inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telehealth
Telehealth participants will be recruited from centers that have a telehealth blood pressure station installed.
Participants will be asked to use the station once per week.
Blood pressure measures will be monitored by nurse researchers - out of range values will result in appropriate medical recommendations.
|
Use of telehealth blood pressure station every week
|
Active Comparator: Control
Control participants will receive education material.
|
Control
|
What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of participants with blood pressure within range
Time Frame: 10 months
|
10 months
|
Number of physician visits
Time Frame: 10 months
|
10 months
|
Number of emergency department visits
Time Frame: 10 months
|
10 months
|
Comfort with technology
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helaine E Resnick, PhD, MPH, Association of Homes and Services for the Aging
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHSA290200600024I, TO #2
- HHSA29032001T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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