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HypertensionAHRQNCT00644267

Using a Telemedicine System to Promote Patient Care Among Underserved Individuals

A study testing Telemedicine in people with Hypertension, run by Temple University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We have established a Telemedicine System for chronic disease management. Based on a personal health record, we have successfully used this system in diverse populations, in over 600 patients, and in multiple disease states (heart failure, CVD risk reduction, gestational diabetes). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hypertension
What is being tested?
Telemedicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
1 siteUnited States
Study dates
Apr 2008to Oct 2010
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • uncontrolled hypertension
  • systolic blood pressure > 140
  • access to a telephone or internet

Who cannot join

  • angina
  • cognitive defects, dementia
  • end stage renal disease
  • living in nursing or boarding homes
  • pregnant
  • unable to sign informed consent
  • unable to use a scale, sphygmomanometer, pedometer

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

We have established a Telemedicine System for chronic disease management. Based on a personal health record, we have successfully used this system in diverse populations, in over 600 patients, and in multiple disease states (heart failure, CVD risk reduction, gestational diabetes). In this proposal, we will enhance this Telemedicine system to support patient centered care (PCC) by increasing access, incorporating hypertension treatment guideline, quality measures, automating reminders and feedback for both patients and health care providers.

Inner-city, primarily African-American patients (N=252) with uncontrolled hypertension (BP<140/90 mmHg) and who are followed by primary care physicians will be randomized to either a usual care or a telemedicine group (Telemedicine plus usual care). Blood pressure, weight, BMI, blood glucose and lipids, and physical activity will be measured at baseline and at 6 months. We hypothesize that more subjects in the telemedicine group will achieve goal blood pressure than in the control group. This will occur through increases in knowledge, self-management, shared decision-making, and improved doctor-patient interaction. Primary end- point will be the proportion of subjects who achieve goal blood pressure. Secondary end-points will include:

Rate of self-monitoring, steps per day, weight, CVD knowledge, number of patients at medication guidelines, and increased satisfaction with practice. Telemedicine utilization will also be determined. We believe that telemedicine can facilitate PCC and reduce blood pressure in a cost effective manner.

Read the detailed description

Basic demographic information will be obtained for each subject. The subject's primary care physician's name, contact information, and specialty will be recorded.

All patients will have an initial medical history, physical examination, electrocardiogram, blood studies, urinalysis, height, weight, and blood pressure measurement. Blood pressure measurements will be obtained in the left arm of seated participants after 5 minutes of quiet rest. A minimum of 3 BP readings will be taken. Systolic and diastolic BP will be recorded. Waist circumference will be measured to the nearest 1 cm at the level of the iliac crest while the subject is standing at minimal respiration. A fasting blood sample will be obtained to determine serum cholesterol, LDL, HDL, triglycerides, creatinine, and glucose levels. All participants will receive their values together with a brochure regarding life-style modification (weight loss, smoking cessation, increased physical activity etc as appropriate). The subjects will take a cardiovascular knowledge questionnaire and the CAHPS® Clinician \& Group Survey (CAHPS 2006).

Control Patients. Management of the patient's medical condition will be done by the patient's primary care physician. No restriction will be placed on patient care or the number of office visits with their physician(s). If a subject does not have a primary care physician, we will arrange for the subject to be followed in a Temple based primary care practice. At the final visit at 6 months, the control patients will be given the opportunity to be followed by the telemedicine system.

Computer Training: Patients randomized to the telemedicine group will be trained on use of a computer and the Internet and on how to access the Internet and web-site. Each patient will be instructed on the details of Telemedicine system on a demonstration terminal in the research center. At that time, the patient will be provided with login name and password to gain access to the secure telemedicine site. The patient will make data entries with coaching by the research team.

An important feature of the Telemedicine system will be telephone-based data entry and communication. This will be added to the current Internet-based system using an Interactive Voice Recognition (IVR) system, which will enable information transmitted via telephone or Internet to be collected in the central database. Training on use of the IVR system (i.e., how to respond to prompts) will be incorporated into the patient training program for the Internet.

The study patients randomized to the telemedicine group will be given a sphygmomanometer with memory, a scale if needed, and a pedometer to count their steps per day. The participants will receive instructions regarding proper use of these devices. Initially, the subjects will wear a pedometer for 7 consecutive days and record the total number of steps taken each day to obtain their baseline physical activity level. The participants will be given recommendations for a gradual progression toward 10,000 steps/day. Ten thousand steps per day are consistent with approximately 5 miles of walking per day. All participants will be given a logbook and encouraged to record their measurements at least once a week (i.e., blood pressure, weight, average number of steps) over the course of the study. Life style changes, increased exercise and weight loss, can make a significant impact on blood pressure; a weight loss of as little as 10 lbs can reduce blood pressure.

Patients in the telemedicine group will also be provided with a toll-free number with which to access the IVR system (a separate toll-free number will be provided to Hispanic patients for a Spanish language IVR system). This system can be used as an alternate to the web-based data entry screens available to all patients in the Internet arm. Basically, the patient will dial the 800 number and a voice message will ask for the patient ID and password (character strings entered via telephone keypad or spoken in sequence). The numerical values for blood pressure, steps, weight, and cigarettes smoked can be entered via voice recognition or by the keypad. Voice messages from the patient will also be permitted. These will be spoken after a prompt, and will be designed to provide a short (i.e. 1 minute) voice transmission that will be stored as a voice file (WAV) to the telemedicine system database. Data entered via the IVR system will be inserted into the patient's personal health record stored in the Telemedicine database.

Conditions
Hypertension
Being tested
Telemedicine
Keywords
hypertension, cardiovascular risk, risk score
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemedicineBehavioural

    Also called Internet, world wide web

    Telemedicine reporting of blood pressure, weight, physical activity

Study groups in NCT00644267
Study groupRoleWhat they receive
1Active comparatorSubjects will use a telemedicine system for blood pressure control
Receives: Behavioral: Telemedicine
2No interventionPatients with hypertension receiving usual care by a primary care physician
Receives: Behavioral: Telemedicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects

    Measured: 6 months

Secondary outcomes (1)
  1. significant reduction in systolic blood pressure in the telemedicine arm

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionOct 2010 (estimated)
  4. Study completionOct 2010 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00644267
Sponsor's protocol ID
AHRQ (DHHS)-1R18HS017202
Other IDs
AHRQ-1R18HS017202
Acronym
AHRQ
Status last verified
Sep 2010
First submitted
24 Mar 2008
Last updated
1 Oct 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Bove AA, Homko CJ, Santamore WP, Kashem M, Kerper M, Elliott DJ. Managing hypertension in urban underserved subjects using telemedicine--a clinical trial. Am Heart J. 2013 Apr;165(4):615-21. doi: 10.1016/j.ahj.2013.01.004. Epub 2013 Mar 6.

    PubMed 23537980

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine in people with Hypertension, run by Temple University at 1 site 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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.

What does the primary outcome measure?

Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00644267, which also lists 1 linked publication.

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 1 Oct 2010.

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