HypertensionTEAhMNCT00987025
Initial Evaluation of Telehealth Blood Pressure Stations in Nutrition Centers
A study testing Telehealth and Educational materials in people with Hypertension, run by LeadingAge at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telehealth and Educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Logan County Friendly Senior Center
Bellefontaine, Ohio, 43311
Miamisburg Senior Adult Center
Miamisburg, Ohio, 45342
Spring Valley Senior Center
Spring Valley, Ohio, 45385
Urbana-Champaign County Senior Center
Urbana, Ohio, 43078
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Telehealth, Educational materials
- Keywords
- hypertension, telehealth, nurse monitor, nutrition center
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthBehavioural
Use of telehealth blood pressure station every week
Educational materialsBehavioural
Control
| Study group | Role | What they receive |
|---|---|---|
| Telehealth | Experimental | 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. Receives: Behavioral: Telehealth |
| Control | Active comparator | Control participants will receive education material. Receives: Behavioral: Educational materials |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LeadingAge
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Wright State University, Healthanywhere Inc.
- Responsible party
- Sponsor
- Investigators
- Helaine E Resnick, PhD, MPH, Principal investigator, Association of Homes and Services for the Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987025
- Sponsor's protocol ID
- HHSA290200600024I, TO #2
- Other IDs
- HHSA29032001T
- Acronym
- TEAhM
- Status last verified
- Feb 2025
- First submitted
- 29 Sep 2009
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technologies for Enhancing Access and Health Management
- ClinicalTrials.gov ID
- NCT00987025
- Acronym / sponsor ID
- TEAhM / HHSA290200600024I, TO #2
- Conditions
- Hypertension
- Keywords
- hypertension, telehealth, nurse monitor, nutrition center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- LeadingAgeUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Wright State University, Healthanywhere Inc.
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Experimental | Behavioral: TelehealthTelehealth 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 | Active comparator | Behavioral: Educational materialsControl participants will receive education material. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelehealthUse of telehealth blood pressure station every week | Behavioural | Telehealth |
| Educational materialsControl | Behavioural | Control |
Primary outcome
Not reported in the source record.
4 secondary outcomes
Proportion of participants with blood pressure within range
Time frame: 10 months
Number of physician visits
Time frame: 10 months
Number of emergency department visits
Time frame: 10 months
Comfort with technology
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helaine E Resnick, PhD, MPH principal investigator
Association of Homes and Services for the Aging
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth and Educational materials in people with Hypertension, run by LeadingAge at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.