Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention

Tobacco Cessation Clinical Trial

Official title:

Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention: Testing the Feasibility of the Textto4gotobacco Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510716
• Other study ID #: Pro00064813
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: October 19, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Over 60 years of age,

2. Have smoked 100 cigarettes in their lifetime and currently smoke five or more cigarettes a day on average,

3. Have an address in a rural census tract defined by a RUCA code of 4-10,

4. Interested in participating in a cessation program,

5. Own a phone that has texting ability and free texting,

6. Have general knowledge of text messaging and

7. Are willing to receive and respond to text messages from the study teams, throughout the duration of the study.

Exclusion Criteria:

1. criteria include non-English speaking patients

2. already participating in a smoking cessation intervention study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

Behavioral:
• SGR

• Support message only

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Alliance for Clinical Trials in Oncology, Duke Cancer Institute, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Feasibility, as measured by proportion of return text messages	Proportion of return text messages sent per participants upon receiving "alert" text messages to use tobacco in the intervention group at 30 days Proportion of SMS support messages opened and/or read per participant	30 days	No
Secondary	Acceptability, as measured by percentage of participants who reported that they would recommend the program to a friend	Percentage of participants who reported that they would recommend the program to a friend	30 days	No