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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth
Educational materials
Sponsored by
American Association of Homes and Services for the Aging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring hypertension, telehealth, nurse monitor, nutrition center

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Logan County Friendly Senior Center
  • Miamisburg Senior Adult Center
  • Spring Valley Senior Center
  • Urbana-Champaign County Senior Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehealth

Control

Arm Description

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.

Control participants will receive education material.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Proportion of participants with blood pressure within range
Number of physician visits
Number of emergency department visits
Comfort with technology

Full Information

First Posted
September 29, 2009
Last Updated
May 27, 2010
Sponsor
American Association of Homes and Services for the Aging
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Wright State University, Healthanywhere Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00987025
Brief Title
Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers
Acronym
TEAhM
Official Title
Technologies for Enhancing Access and Health Management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
American Association of Homes and Services for the Aging
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Wright State University, Healthanywhere Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, telehealth, nurse monitor, nutrition center

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control participants will receive education material.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth
Intervention Description
Use of telehealth blood pressure station every week
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
Control
Secondary Outcome Measure Information:
Title
Proportion of participants with blood pressure within range
Time Frame
10 months
Title
Number of physician visits
Time Frame
10 months
Title
Number of emergency department visits
Time Frame
10 months
Title
Comfort with technology
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helaine E Resnick, PhD, MPH
Organizational Affiliation
Association of Homes and Services for the Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan County Friendly Senior Center
City
Bellefontaine
State/Province
Ohio
ZIP/Postal Code
43311
Country
United States
Facility Name
Miamisburg Senior Adult Center
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
Spring Valley Senior Center
City
Spring Valley
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Urbana-Champaign County Senior Center
City
Urbana
State/Province
Ohio
ZIP/Postal Code
43078
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers

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