Expired Study
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Wichita, Kansas 67214


Purpose:

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).


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

STUDY00003190


NCT ID:

NCT02622282


Secondary ID:

R56AG047590


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kansas Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

69


Enrollment Type:

Actual


Overall Contact Information

Official Name:Tracie C. Collins, MD, MPH
Principal Investigator
University of Kansas Medical Center

Study Dates

Start Date:May 2016
Completion Date:December 2016
Completion Type:Actual
Primary Completion Date:December 2016
Primary Completion Type:Actual
Verification Date:February 2017
Last Changed Date:February 1, 2017
First Received Date:December 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Quality of Life
Time Frame:Change from Baseline to 3 Months
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change in Exercise Behavior
Time Frame:Change from Baseline to 3 Months
Safety Issues:False
Description:Change will be measured using the Exercise Behaviors Survey.
Outcome Type:Primary Outcome
Measure:Change in Physical Activity
Time Frame:Change from Baseline to 3 Months
Safety Issues:False
Description:All participants will use a pedometer. Mean change will be measured based on steps per day.

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:Experimental Group
Description: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.
Study Arm Type:Active Comparator
Arm Name:Control Group
Description:Participants will receive a handout with information on PAD and physical activity.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kansas Medical Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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