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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by American Association of Homes and Services for the Aging.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Wright State University
Healthanywhere Inc.
Information provided by:
American Association of Homes and Services for the Aging
ClinicalTrials.gov Identifier:
NCT00987025
First received: September 29, 2009
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Telehealth
Behavioral: Educational materials

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Technologies for Enhancing Access and Health Management

Resource links provided by NLM:


Further study details as provided by American Association of Homes and Services for the Aging:

Secondary Outcome Measures:
  • Proportion of participants with blood pressure within range [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Number of physician visits [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Number of emergency department visits [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Comfort with technology [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: October 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Telehealth
Use of telehealth blood pressure station every week
Active Comparator: Control
Control participants will receive education material.
Behavioral: Educational materials
Control

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987025

Locations
United States, Ohio
Logan County Friendly Senior Center
Bellefontaine, Ohio, United States, 43311
Miamisburg Senior Adult Center
Miamisburg, Ohio, United States, 45342
Spring Valley Senior Center
Spring Valley, Ohio, United States, 45385
Urbana-Champaign County Senior Center
Urbana, Ohio, United States, 43078
Sponsors and Collaborators
American Association of Homes and Services for the Aging
Wright State University
Healthanywhere Inc.
Investigators
Principal Investigator: Helaine E Resnick, PhD, MPH Association of Homes and Services for the Aging
  More Information

No publications provided

Responsible Party: Helaine Resnick, PhD, MPH/ Principal Investigator, Association of Homes and Services for the Aging
ClinicalTrials.gov Identifier: NCT00987025     History of Changes
Other Study ID Numbers: HHSA290200600024I, TO #2, HHSA29032001T
Study First Received: September 29, 2009
Last Updated: May 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by American Association of Homes and Services for the Aging:
hypertension
telehealth
nurse monitor
nutrition center

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014