HypertensionNCT05062473
Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
A study of Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 1 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female greater than or equal to 18 years of age.
- Self-report of a hypertension diagnosis.
Who cannot join
- Pregnant or breastfeeding.
- End-stage renal disease on hemodialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
The purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community.
- Conditions
- Hypertension
- Being tested
- Lifestyle Modification Webinars Focused on Hypertension Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Modification Webinars Focused on Hypertension ControlBehavioural
Participation in a 12-week health education telemedicine curriculum
| Study group | Role | What they receive |
|---|---|---|
| Hypertension telemedicine curriculum | Other | All participants participate in the 12-week telemedicine curriculum. All participants will be asked to record their steps via pedometer and their blood pressure measurements via automatic blood pressure arm cuff. Receives: Behavioral: Lifestyle Modification Webinars Focused on Hypertension Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Satisfaction with the Curriculum at 12 Weeks
Participant's satisfaction with the curriculum will be measured via 5-point Likert scale survey that was created by our research team. Scores will range from a low of "Strongly disagree" to a high of "Strongly agree."
Measured: Week 12
Change in Number of Participants Virtually Attending the Health Education Seminars
Virtual attendance to the health education seminars will be collected. The number of participants who virtually attend all health education seminars over the 12 week period will be collected and change in number of participants attending will be assessed.
Measured: Baseline to 12 weeks.
Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings
Participant's rate of completion of the weekly blood pressure recording logs will be measured and analyzed.
Measured: Baseline to 12 weeks.
Change in Participant's Rate of Completion of Weekly Steps Recordings
Participant's rate of completion of the weekly step recording logs will be measured and analyzed.
Measured: Baseline to 12 weeks.
Secondary outcomes (4)
Mean Change in Systolic Blood Pressure Measurement.
Participants will self-report weekly up to 4 blood pressure readings taken at baseline through week 12 with their automatic blood pressure arm cuff. The change in systolic blood pressure measurements in this time frame will be assessed.
Measured: Baseline to week 12
Mean Change in Diastolic Blood Pressure Measurement.
Participants will self-report weekly up to 4 blood pressure readings taken at baseline through week 12 with their automatic blood pressure arm cuff. The change in diastolic blood pressure measurements in this time frame will be assessed.
Measured: Baseline to week 12
Mean Change in Number of Daily Steps Measured by Pedometer.
Participants will self-report weekly the number of steps taken as measured by their wrist pedometer at baseline through week 12.
Measured: Baseline to week 12
Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey.
The name of the survey is " Knowledge, attitudes, and perceptions towards hypertension and cardiovascular disease." The survey was adapted from the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. It consists of both quantitative and qualitative questions assessing participants' demographics, participants' knowledge and attitudes about diet and exercise, and participants' knowledge about hypertension and other related cardiac diseases (i.e. stroke, coronary artery disease). The survey will be administered at enrollment and post-intervention at week 12. Pre- and post-surveys will be compared for accuracy of answers and change in self-reported behaviors.
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start4 Oct 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Tracy K Paul, MD, Principal investigator, Weill Cornell Medicine/NY Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062473
- Sponsor's protocol ID
- 20-10022836
- Other IDs
- 1 T1NHP391850100.
- Status last verified
- Oct 2023
- First submitted
- 2 Sep 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Artinian NT, Washington OG, Templin TN. Effects of home telemonitoring and community-based monitoring on blood pressure control in urban African Americans: a pilot study. Heart Lung. 2001 May-Jun;30(3):191-9. doi: 10.1067/mhl.2001.112684.
PubMed 11343005Liu S, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Effectiveness of User- and Expert-Driven Web-based Hypertension Programs: an RCT. Am J Prev Med. 2018 Apr;54(4):576-583. doi: 10.1016/j.amepre.2018.01.009. Epub 2018 Feb 16.
PubMed 29456025Bove 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
- ClinicalTrials.gov ID
- NCT05062473
- Acronym / sponsor ID
- 20-10022836
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Sep 2021 (actual)
- 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 this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertension telemedicine curriculum | Other | Behavioral: Lifestyle Modification Webinars Focused on Hypertension ControlAll participants participate in the 12-week telemedicine curriculum. All participants will be asked to record their steps via pedometer and their blood pressure measurements via automatic blood pressure arm cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female greater than or equal to 18 years of age.
- Self-report of a hypertension diagnosis.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding.
- End-stage renal disease on hemodialysis.
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 |
|---|---|---|
| Lifestyle Modification Webinars Focused on Hypertension ControlParticipation in a 12-week health education telemedicine curriculum | Behavioural | Hypertension telemedicine curriculum |
Primary outcome
Participant's Satisfaction with the Curriculum at 12 Weeks
Time frame: Week 12
Participant's satisfaction with the curriculum will be measured via 5-point Likert scale survey that was created by our research team. Scores will range from a low of "Strongly disagree" to a high of "Strongly agree."
Change in Number of Participants Virtually Attending the Health Education Seminars
Time frame: Baseline to 12 weeks.
Virtual attendance to the health education seminars will be collected. The number of participants who virtually attend all health education seminars over the 12 week period will be collected and change in number of participants attending will be assessed.
Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings
Time frame: Baseline to 12 weeks.
Participant's rate of completion of the weekly blood pressure recording logs will be measured and analyzed.
Change in Participant's Rate of Completion of Weekly Steps Recordings
Time frame: Baseline to 12 weeks.
Participant's rate of completion of the weekly step recording logs will be measured and analyzed.
4 secondary outcomes
Mean Change in Systolic Blood Pressure Measurement.
Time frame: Baseline to week 12
Mean Change in Diastolic Blood Pressure Measurement.
Time frame: Baseline to week 12
Mean Change in Number of Daily Steps Measured by Pedometer.
Time frame: Baseline to week 12
Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey.
Time frame: Baseline, week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 11343005Artinian NT, Washington OG, Templin TN. Effects of home telemonitoring and community-based monitoring on blood pressure control in urban African Americans: a pilot study. Heart Lung. 2001 May-Jun;30(3):191-9. doi: 10.1067/mhl.2001.112684.
- Background: PubMed 29456025Liu S, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Effectiveness of User- and Expert-Driven Web-based Hypertension Programs: an RCT. Am J Prev Med. 2018 Apr;54(4):576-583. doi: 10.1016/j.amepre.2018.01.009. Epub 2018 Feb 16.
- Background: PubMed 23537980Bove 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.
- Hypertension Hospitalizations and Related Morbidity in New York CityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tracy K Paul, MD principal investigator
Weill Cornell Medicine/NY Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypertension, run by Weill Medical College of Cornell 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Nov 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Participant's Satisfaction with the Curriculum at 12 Weeks (time frame: Week 12). The study lists 4 primary outcomes in all. 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 NCT05062473, which also lists 3 linked publications.
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 Nov 2023.