NCT05910255

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 9, 2023

Last Update Submit

June 9, 2023

Conditions

Keywords

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Number of hypertension patients who decide to join in a clinical study

    3 months

  • Rate of patients who remain in a hypertension clinical study to completion

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with hypertension who are actively participating in a clinical research, but have not yet completed enrollment and randomization.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

  • 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.

    PMID: 35978336BACKGROUND
  • 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.

    PMID: 30131071BACKGROUND
  • 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.

    PMID: 29180263BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2026

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations