NCT02986711

Brief Summary

This study aims to pilot a method of collecting the post-discharge follow-up data required by the Joint Commission Tobacco Measure Set, using text messages sent to and received from patients' cellular-telephones. It also aims to assess whether specially designed relapse prevention text messages designed to encourage abstinence from smoking, can increase the proportion of smokers who remain abstinent during the first month after discharge from hospital.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

October 8, 2015

Results QC Date

January 11, 2018

Last Update Submit

December 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million).

    Abstinence rate at 28 days

    28 days

Secondary Outcomes (1)

  • Proportion of Participants Providing Smoking Cessation Status Via Text Message

    28 days

Study Arms (2)

Motivational Text Messages

EXPERIMENTAL

Motivational text messages to help participants stay quit when they leave the hospital.

Behavioral: Motivational Text Messages

Control

SHAM COMPARATOR

Text messages to ask about current smoking status.

Behavioral: Control

Interventions

Motivational text messages in addition to survey questions about smoking status

Motivational Text Messages
ControlBEHAVIORAL

Only survey questions about smoking status

Control

Eligibility Criteria

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

You may qualify if:

  • Total length of hospital stay at least 24 hours
  • Free of cognitive impairment
  • Read and speak English
  • Smoked at least 20 cigarettes in 30 days prior to entering the hospital
  • Willing to give up all forms of tobacco
  • Has a cell phone capable of receiving text messages (cell phone is powered on and charged)

You may not qualify if:

  • Patient has been admitted for a transplant
  • Patient has Intensive Care status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Jessica Yingst
Organization
Penn State University College of Medicine

Study Officials

  • Jonathan Foulds, PhD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2015

First Posted

December 8, 2016

Study Start

December 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 19, 2018

Results First Posted

September 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations