Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers (TEAhM)

Technologies for Enhancing Access and Health Management

The purpose of TEAhM is to determine if telehealth blood pressure stations can be installed and used in senior nutrition centers and to do a preliminary comparison of blood pressure outcomes among nutrition center clients who use the telehealth blood pressure stations compared to participants who do not use the stations. Specifically, the goals of the project are to determine if these monitors can be successfully implemented in this community-based setting, the degree to which older adults with hypertension are comfortable using the technology, and whether remote nurse monitoring of blood pressure using this technology is a feasible supplement to office-based care.

Study Overview

Status

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Bellefontaine, Ohio, United States, 43311
        • Logan County Friendly Senior Center
      • Miamisburg, Ohio, United States, 45342
        • Miamisburg Senior Adult Center
      • Spring Valley, Ohio, United States, 45385
        • Spring Valley Senior Center
      • Urbana, Ohio, United States, 43078
        • Urbana-Champaign County Senior Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helaine E Resnick, PhD, MPH, Association of Homes and Services for the Aging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

May 1, 2010

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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