Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Other: Text Messages; Other: Phone Calls; Other: Handout

• Registration Number: NCT02622282
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to learn about the impact of text messaging on physical activity in persons with risk factors for peripheral arterial disease (PAD).

Detailed Description

Thirty-five million Latinos live in the U.S. and nearly 14% have peripheral arterial disease (PAD) defined as a build-up of plaque in the arteries that supply blood to the legs. Approximately 40% have at least one risk for PAD (i.e., aged 70 years and older, diabetes, high blood pressure, high blood cholesterol, or smoking). Persons with at least one risk factor and who are physically inactive are more likely to suffer from severe PAD. Physical inactivity is highly prevalent in Latinos and a major risk factor for PAD. Physical inactivity affects 50% of Latinos aged 60 years and older.

Participation in this study will last for about 3 months. Participants will be randomized to one of two groups. One group will receive text messages, brief telephone calls, and a handout. The other group will only receive the handout. The study will be looking at how the different groups respond to the different interventions used in the study.

Study Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Study Start: 2016-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Latino adults
• English or Spanish speaking
• Have one or more of the following: diabetes mellitus, smoking, hypertension, or hyperlipidemia.
• Adults age 70 years or older, regardless of having one or more the above noted risk factors for PAD, will also be eligible for enrollment.

Exclusion Criteria

• Pregnancy
• Prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers)
• Use of supplemental oxygen
• Myocardial infarction within preceding 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Handout	Participants will receive text messages and telephone calls during the length of their participation. Participants will receive a handout with information on PAD and physical activity.
Control Group	Handout	Participants will receive a handout with information on PAD and physical activity.
Experimental Group	Phone Calls	Participants will receive text messages and telephone calls during the length of their participation. Participants will receive a handout with information on PAD and physical activity.
Experimental Group	Text Messages	Participants will receive text messages and telephone calls during the length of their participation. Participants will receive a handout with information on PAD and physical activity.

Primary Outcome Measures

Name	Time	Method
Change in Physical Activity	Change from Baseline to 3 Months	All participants will use a pedometer. Mean change will be measured based on steps per day.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	Change from Baseline to 3 Months	Change will be measured using the Medical Outcomes Study (MOS) Short Form 36. The survey has 36 questions. Scores are coded based on response by participant. A score of 100 indicates the most favorable situation while a score of 0 would indicate the least favorable.
Change in Exercise Behavior	Change from Baseline to 3 Months	Change will be measured using the Exercise Behaviors Survey.

Trial Locations

Locations (1)

KU School of Medicine - Wichita; 🇺🇸 Wichita, Kansas, United States