Hypertension Clinical Trial
Official title:
An In Depth Study Exploring Patient Experiences of Individuals Participating in Hypertension Clinical Trials
| NCT number | NCT05910255 |
| Other study ID # | 87814554 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2024 |
| Est. completion date | July 2026 |
This research study aims to identify the obstacles faced by specific demographic groups of hypertension patients during their engagement in clinical trials. The study will collect in-depth information from participants and identify common factors that impede their enrollment or successful completion of these trials. By examining data from various demographic perspectives, the study aims to identify patterns impacting future hypertension patients' experiences.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | July 2026 |
| Est. primary completion date | July 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient is at least 18 years of age - Diagnosis of hypertension - Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Exclusion Criteria: - Enrolled in another research study - Inability to provide written informed consent - Women of childbearing potential without a negative pregnancy test; or women who are lactating. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
Cimmaruta D, Lombardi N, Borghi C, Rosano G, Rossi F, Mugelli A. Polypill, hypertension and medication adherence: The solution strategy? Int J Cardiol. 2018 Feb 1;252:181-186. doi: 10.1016/j.ijcard.2017.11.075. Epub 2017 Nov 23. — View Citation
Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3. — View Citation
Noone C, Dwyer CP, Murphy J, Newell J, Molloy GJ. Comparative effectiveness of physical activity interventions and anti-hypertensive pharmacological interventions in reducing blood pressure in people with hypertension: protocol for a systematic review and network meta-analysis. Syst Rev. 2018 Aug 21;7(1):128. doi: 10.1186/s13643-018-0791-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of hypertension patients who decide to join in a clinical study | 3 months | ||
| Primary | Rate of patients who remain in a hypertension clinical study to completion | 12 months |
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|---|---|---|---|
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