UW Hospital and Clinics
Madison, Wisconsin, 53792, United States
NCT Number: NCT05685251
A study of Staying Healthy After Childbirth (STAC) and My Hypertension Education And Reaching Target (MyHEART) for postpartum (p) patients to determine if health coaching can increase 12-month postpartum care attendance, hypertension control and hypertension self-management behavior compared to usual clinical care in patients with chronic hypertension or persistent pregnancy associated hypertension - postpartum. 140 participants will be enrolled and can expect to be on study for 12 months.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
To address the critical need for hypertension (HTN) control in young adults, the investigators developed the MyHEART (My Hypertension Education And Reaching Target) program, a multi-component patient-centered, theoretically-based intervention designed to increase self-management using evidence-based health behavior approaches to lower BP among young adults with uncontrolled HTN.
A nonrandomized, single-center pilot study of MyHEART was conducted, which established feasibility, satisfaction, and informed the design of this trial. A large, multi-site randomized-controlled trial to evaluate the effect of MyHEART (home blood pressure monitor distribution and heath coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary) and HTN control (secondary) after 6 and 12 months, compared to usual clinical care was completed. Additionally, lifestyle changes and HTN self-management behavior were evaluated.
Incorporating components of the MyHEART intervention with routine clinical care can support HTN behavioral changes in young adults with uncontrolled HTN to support BP lowering in this population. The investigators are in a unique position to partner with the Perinatal Clinic and the current STAC program, to improve health outcomes for women with HTN during pregnancy through health coaching and BP surveillance through 12-months postpartum.
Specific Aims:
Aim 1-3: A total of 140 participants will be enrolled and randomly assigned to the intervention and usual care arms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a health coach telehealth/video visit or phone call every 2 weeks for 4 months, for a total of 8 calls. After these initial 8 calls, at approximately 6 months postpartum, the health coach will schedule maintenance calls 1 per month until approximately 12 months postpartum, for a total of 6 additional calls.
Participants will be provided an A&D UA-651 (BT) home blood pressure monitor with an appropriate cuff size, they will be asked to take their blood pressure at least three days a week, 2 measurements each time
Time frame: up to 12 months
Time frame: up to 6 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Hypertension control will be defined using ambulatory blood pressures as the gold standard (less than 130/80 mmHg); otherwise a clinic blood pressure of less than 140/90 mmHg will be used.
Time frame: up to 12 months
Time frame: up to 12 months
Time frame: 6 and 12 months
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by dietary changes documented on an automated self-administered 24 hour dietary assessment.
Time frame: 6 and 12 months
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by change in physical activity as measured by the Godin Physical Activity Questionnaire at 6 and 12 months. The Godin Physical Activity Questionnaire measures a person's strenuous, moderate, and light physical activity in a week. A score of less than 14 is interpreted as insufficiently active or sedentary, a score between 14 and 23 is interpreted to be moderately active, and a score of 24 and higher is interpreted to be active.
Time frame: 6 and 12 months
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by measuring the frequency of home blood pressure monitoring.
Time frame: 6 and 12 months
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant weight at 6 and 12 months.
Time frame: 6 and 12 months
Change in hypertension self-management behavior at 6 and 12 months compared to usual care will in part be assessed by documenting participant BMI at 6 and 12 months.
University of Wisconsin, Madison
Other
Staying Healthy After Childbirth: My Hypertension Education and Reaching Target Program for Postpartum (STAC-MyHEARTp)
Acronym: STAC-MyHEARTp
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02055209
Cardiovascular Diseases, Hypertension
Bethesda, Maryland, United States
View Trial DetailsNCT02290392
Cardiovascular Diseases, Hypertension
Bethesda, Maryland, United States
View Trial DetailsNCT05610059
Aging, Behavior
Tucson, Arizona, United States
View Trial DetailsNCT02439775
Cardiovascular Diseases, Hypertension
Huntsville, Alabama, United States
View Trial Details