Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers

Hypertension Clinical Trial

— TEAhM  

Official title:

Technologies for Enhancing Access and Health Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00987025
• Other study ID #: HHSA290200600024I, TO #2
• Secondary ID: HHSA29032001T
• Status: Active, not recruiting
• Phase: N/A
• First received: September 29, 2009
• Last updated: May 27, 2010
• Start date: October 2009
• Est. completion date: January 2011

Study information

• Verified date: May 2010
• Source: American Association of Homes and Services for the Aging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Telehealth
Use of telehealth blood pressure station every week
• Educational materials
Control

Locations

Country	Name	City	State
United States	Logan County Friendly Senior Center	Bellefontaine	Ohio
United States	Miamisburg Senior Adult Center	Miamisburg	Ohio
United States	Spring Valley Senior Center	Spring Valley	Ohio
United States	Urbana-Champaign County Senior Center	Urbana	Ohio

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Proportion of participants with blood pressure within range		10 months	No
Secondary	Number of physician visits		10 months	No
Secondary	Number of emergency department visits		10 months	No
Secondary	Comfort with technology		10 months	No