Clinical trial NCT05910255: A Detailed Look At What Patients Experience When They Take Part In Hypertension Clinical Trials
Official title: An In Depth Study Exploring Patient Experiences of Individuals Participating in Hypertension Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hypertension who are actively participating in a clinical research, but have not yet completed enrollment and randomization.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of hypertension patients who decide to join in a clinical study
timeFrame: 3 months
measure: Rate of patients who remain in a hypertension clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.