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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622282
• Other study ID #: STUDY00003190
• Secondary ID: R56AG047590
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: February 1, 2017
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Text Messages
Text messages will be sent one time per day. Text messages will include messages to motivate and inform participants on the importance of walking.
• Phone Calls
Participants may receive a telephone call every two weeks for one month followed by once per month for two months.
• Handout
Handout includes information specific to participant's condition and ways to promote an active lifestyle.

Locations

Country	Name	City	State
United States	KU School of Medicine - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Exercise Behavior	Change will be measured using the Exercise Behaviors Survey.	Change from Baseline to 3 Months
Secondary	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