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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Text Messaging to Promote Walking Among Latino Adults at Risk for PAD

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Text Messages
* Other: Phone Calls
* Other: Handout


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Other: Text Messages<br>* Text messages will be sent one time per day. Text messages will include messages to motivate and inform participants on the importance of walking.<br>Other: Phone Calls<br>* Participants may receive a telephone call every two weeks for one month followed by once per month for two months.<br>Other: Handout<br>* Handout includes information specific to participant's condition and ways to promote an active lifestyle.<br>|
| Active Comparator: Control Group<br>Participants will receive a handout with information on PAD and physical activity. | Other: Handout<br>* Handout includes information specific to participant's condition and ways to promote an active lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity | All participants will use a pedometer. Mean change will be measured based on steps per day. | Change from Baseline to 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise Behavior | Change will be measured using the Exercise Behaviors Survey. | Change from Baseline to 3 Months | 
| Change in Quality of Life | 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 from Baseline to 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, physical activity, physical inactivity, PAD, Diabetes, High blood pressure, High cholesterol