NCT03020836

Brief Summary

Investigators conducted a clinic-based study to determine the magnitude of uncontrolled hypertension and current smoking in eye doctor's offices and sought to determine if referral to care results in actions taken by the patient.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
473

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Apr 2015

Status
completed

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

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

January 10, 2017

Last Update Submit

January 12, 2017

Conditions

HypertensionSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with elevated blood pressure

    1 day (at study clinic visit)

Secondary Outcomes (3)

  • Proportion of patients that are current smokers

    1 day (at study clinic visit)

  • Proportion of patients with elevated blood pressure that sought referral care

    From study visit to 10 weeks after

  • Proportion of patients that were current smokers that sought referral quit line assistance

    From study visit to 10 weeks after

Study Arms (2)

Hypertension patient referral

OTHER

Referral to primary care physician for hypertension control: Patients with uncontrolled hypertension were referred to a primary care physician for treatment.

Behavioral: Referral to primary care physician for hypertension control

Smoking cessation patient referral

OTHER

Referral to smoking quit line: Patients that were current smokers were referred to the Maryland smoking cessation quit line if they were willing.

Behavioral: Referral to smoking quit line

Interventions

Referral to primary care physician for hypertension controlBEHAVIORAL

Referral to primary care physician for hypertension control

Hypertension patient referral
Referral to smoking quit lineBEHAVIORAL

Referral to Maryland Tobacco/Smoking quit line for help with smoking cessation

Smoking cessation patient referral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>18 years of age presenting to the glaucoma service and general eye service at Wilmer Eye Institute.

You may not qualify if:

  • Non-English speakers
  • Unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionSmoking Cessation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 13, 2017

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share