NCT03680599

Brief Summary

The goal of the study is to develop and test Connection to Health for Smokers (CTHS), a comprehensive program to support smokers to quit and improve smokers' general health. The program will be designed for implementation by health educators in community health centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

September 19, 2018

Last Update Submit

March 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Program Reach, Effectiveness, Adoption, Implementation, and Maintenance

    The RE-AIM Framework will be used to assess program feasibility

    3 months

Secondary Outcomes (1)

  • 7-day smoking abstinence

    3 months

Study Arms (2)

Connection to Health for Smokers

EXPERIMENTAL

Participants in this arm will participate in the Connection to Health for Smokers Arm of the study, wherein an electronic survey will be administered and participants will be guided through an evidence-based action planning sequence, taking into account each patient's unique social environment, health related behaviors, and behavioral health status, with multimodal follow up.

Behavioral: Connection to Health for Smokers

Enhanced Standard of Care

ACTIVE COMPARATOR

Participants in this arm will participate in Enhanced Standard Care, wherein participants will receive a brief electronic survey and receive standard smoking cessation program that does not include formal action planning and multimodal follow up.

Behavioral: Enhanced Standard of Care

Interventions

Connection to Health for Smokers includes 5 core components supported by online tools: (1) comprehensive electronic patient survey, (2) automated summary report to flag areas of difficulty (3) interactive priority setting, (4) interactive action planning, and (5) electronic text reminders and followup.

Connection to Health for Smokers

Participants will complete a survey and receive standard one-on-one smoking cessation according to a usual care protocol delivered by health educators

Enhanced Standard of Care

Eligibility Criteria

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

You may qualify if:

  • \- Must have smoked cigarettes in the last 7 days

You may not qualify if:

  • \- Speaking languages other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Michael Potter, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 21, 2018

Study Start

January 3, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations