Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messages
Phone Calls
Handout
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Arterial Disease focused on measuring physical activity, physical inactivity, PAD, Diabetes, High blood pressure, High cholesterol, Smoking
Eligibility 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
Sites / Locations
- KU School of Medicine - Wichita
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm 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.
Participants will receive a handout with information on PAD and physical activity.
Outcomes
Primary Outcome Measures
Change in Physical Activity
All participants will use a pedometer. Mean change will be measured based on steps per day.
Secondary Outcome Measures
Change in Exercise Behavior
Change will be measured using the Exercise Behaviors Survey.
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.
Full Information
NCT ID
NCT02622282
First Posted
December 2, 2015
Last Updated
February 1, 2017
Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT02622282
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
physical activity, physical inactivity, PAD, Diabetes, High blood pressure, High cholesterol, Smoking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants will receive a handout with information on PAD and physical activity.
Intervention Type
Other
Intervention Name(s)
Text Messages
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Phone Calls
Intervention Description
Participants may receive a telephone call every two weeks for one month followed by once per month for two months.
Intervention Type
Other
Intervention Name(s)
Handout
Intervention Description
Handout includes information specific to participant's condition and ways to promote an active lifestyle.
Primary Outcome Measure Information:
Title
Change in Physical Activity
Description
All participants will use a pedometer. Mean change will be measured based on steps per day.
Time Frame
Change from Baseline to 3 Months
Secondary Outcome Measure Information:
Title
Change in Exercise Behavior
Description
Change will be measured using the Exercise Behaviors Survey.
Time Frame
Change from Baseline to 3 Months
Title
Change in Quality of Life
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 favorable.
Time Frame
Change from Baseline to 3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracie C. Collins, MD, MPH
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU School of Medicine - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31453076
Citation
Collins TC, Lu L, Valverde MG, Silva MX, Parra-Medina D. Efficacy of a multi-component intervention to promote physical activity among Latino adults: A randomized controlled trial. Prev Med Rep. 2019 Aug 7;16:100965. doi: 10.1016/j.pmedr.2019.100965. eCollection 2019 Dec.
Results Reference
derived
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Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease
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