NCT02510716

Brief Summary

The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via SMS (short message service) text messaging plus SMS Support Messages in decreasing smoking in an older adult rural population. The SGR group (n=20) will receive a four-week SGR program delivered via SMS text messages plus SMS support messages. The control group (n=20) will receive SMS support messages to aid in quitting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

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

July 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 21, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

July 24, 2015

Last Update Submit

October 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tobacco cessation, defined as quit rate at 30 days, as measured by self-reported abstinence from tobacco use

    Quit rate at 30 days, as measured by self-reported abstinence from tobacco use

    30-days

Secondary Outcomes (2)

  • Feasibility, as measured by proportion of return text messages

    30 days

  • Acceptability, as measured by percentage of participants who reported that they would recommend the program to a friend

    30 days

Study Arms (2)

Scheduled Gradual Reduction (SGR)

EXPERIMENTAL

Four week SGR program plus support text messages.

Behavioral: SGRBehavioral: Support message only

Support Message Only

ACTIVE COMPARATOR

Support text messages only.

Behavioral: Support message only

Interventions

SGRBEHAVIORAL
Scheduled Gradual Reduction (SGR)
Scheduled Gradual Reduction (SGR)Support Message Only

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 60 years of age,
  • Have smoked 100 cigarettes in their lifetime and currently smoke five or more cigarettes a day on average,
  • Have an address in a rural census tract defined by a RUCA code of 4-10,
  • Interested in participating in a cessation program,
  • Own a phone that has texting ability and free texting,
  • Have general knowledge of text messaging and
  • Are willing to receive and respond to text messages from the study teams, throughout the duration of the study.

You may not qualify if:

  • criteria include non-English speaking patients
  • already participating in a smoking cessation intervention study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Noonan D, Silva S, Njuru J, Bishop T, Fish LJ, Simmons LA, Choi SH, Pollak KI. Feasibility of a text-based smoking cessation intervention in rural older adults. Health Educ Res. 2018 Feb 1;33(1):81-88. doi: 10.1093/her/cyx080.

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 29, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 21, 2016

Record last verified: 2016-08

Locations