Health BehaviormyHEARTNCT02653573
Young Adult Hypertension Feasibility Study
A study testing Coaching in people with Health Behavior and Hypertension, run by University of Wisconsin, Madison.
Trial summary
This study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Health Behavior, Hypertension
- What is being tested?
- Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2016
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-39 years old at the start of the study
- previous hypertension ICD-9 coded office visits
- uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading
Who cannot join
- Chronic Kidney Disease (Stage 4 or 5 or Dialysis)
- Congestive Heart Failure, Any Etiology
- Activated Healthcare Power of Attorney
- Skilled nursing facility or correctional facility residence
- Currently enrolled in case management or chronic disease management support services
- Sensitive condition diagnosis (e.g. HIV)
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- Prescribed warfarin, novel oral anticoagulant, or insulin
- Diagnosis of sickle cell anemia or cystic fibrosis
- Prior stroke, myocardial infarction, coronary artery revascularization
- Syncope within past 12 months
- Prior or planned organ transplant
- Chemotherapy or radiation therapy within 6 months
- Severely impaired hearing or speech
- Current participation in another research study
- Pregnant/planning to become pregnant in the next 12 months
- Planning to leave the area in the next 3 months
- Any health condition that will limit physical activity or dietary changes
- Illegal drug use (other than marijuana) in the past 30 days (Self-report)
- Unable to read or communicate in English
About this study
Official title: myHEART (My Hypertension Education and Reaching Target) Program: a Feasibility Study of a Young Adult Hypertension Intervention
This study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults.
Read the detailed description
To address the unmet need for hypertension care in young adults, MyHEART (My Hypertension Education and Reaching Target), a multi-component hypertension intervention was developed. Eligible patients were identified via the healthcare system's electronic health record.
Inclusion criteria included:
- 18-39 years old at the start of the study,
- previous hypertension ICD-9 coded office visits and
- uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading.
Exclusion criteria included a pre-defined list of co-morbidities, in addition to planned or current pregnancy, any health condition that limits physical activity or dietary changes, current participation in another study, and planning to leave the area in the next three months. During the feasibility study, all participants continued to receive usual hypertension care from their primary care provider. The intervention involved health coach calls over a 3-month period using self-management modules. The order of the modules was guided by the participant's choice. All encounters were documented in the electronic health record. Patient acceptability and home blood pressure monitoring survey data was acquired.
- Conditions
- Health Behavior, Hypertension
- Being tested
- Coaching
- Keywords
- young adult
- Medical subject headings
- Health Behavior, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
Self-management education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telephone health coaching over 3 months with supporting education materials. Receives: Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction survey of feasibility study
Measured: 3 months
Secondary outcomes (1)
Out-of-clinic blood pressures
Frequency of home or out-of-clinic blood pressure monitoring
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather M Johnson, MD, MS, Principal investigator, University of WI School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653573
- Sponsor's protocol ID
- 2014-1297
- Acronym
- myHEART
- Status last verified
- Oct 2016
- First submitted
- 28 Dec 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- myHEART (My Hypertension Education and Reaching Target) Program: a Feasibility Study of a Young Adult Hypertension Intervention
- ClinicalTrials.gov ID
- NCT02653573
- Acronym / sponsor ID
- myHEART / 2014-1297
- Conditions
- Health Behavior, Hypertension
- Keywords
- young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jan 2016 (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.
This study was designed to evaluate the feasibility of a telephone-based health coach self-management intervention for young adults.
Detailed description
To address the unmet need for hypertension care in young adults, MyHEART (My Hypertension Education and Reaching Target), a multi-component hypertension intervention was developed. Eligible patients were identified via the healthcare system's electronic health record.
Inclusion criteria included:
- 18-39 years old at the start of the study,
- previous hypertension ICD-9 coded office visits and
- uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading.
Exclusion criteria included a pre-defined list of co-morbidities, in addition to planned or current pregnancy, any health condition that limits physical activity or dietary changes, current participation in another study, and planning to leave the area in the next three months. During the feasibility study, all participants continued to receive usual hypertension care from their primary care provider. The intervention involved health coach calls over a 3-month period using self-management modules. The order of the modules was guided by the participant's choice. All encounters were documented in the electronic health record. Patient acceptability and home blood pressure monitoring survey data was acquired.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CoachingTelephone health coaching over 3 months with supporting education materials. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-39 years old at the start of the study
- previous hypertension ICD-9 coded office visits
- uncontrolled hypertension (≥140/90 mmHg) based on the last ambulatory blood pressure reading
Key exclusion criteria (19 listed)
- Chronic Kidney Disease (Stage 4 or 5 or Dialysis)
- Congestive Heart Failure, Any Etiology
- Activated Healthcare Power of Attorney
- Skilled nursing facility or correctional facility residence
- Currently enrolled in case management or chronic disease management support services
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 |
|---|---|---|
| CoachingSelf-management education | Behavioural | Intervention |
Primary outcome
Patient Satisfaction
Time frame: 3 months
Patient satisfaction survey of feasibility study
1 secondary outcome
Out-of-clinic blood pressures
Time frame: 3 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 27 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Heather M Johnson, MD, MS principal investigator
University of WI School of Medicine and Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Coaching in people with Health Behavior and Hypertension, run by University of Wisconsin, Madison.
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 19 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Patient Satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 27 Oct 2016.