Peripheral Arterial DiseaseNCT02622282
Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease
A study testing Text Messages, Phone Calls and Handout in people with Peripheral Arterial Disease, run by University of Kansas Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Text Messages, Phone Calls and Handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
KU School of Medicine - Wichita
Wichita, Kansas, 67214
About this study
Official title: Text Messaging to Promote Walking Among Latino Adults at Risk for PAD
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).
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Text Messages, Phone Calls, Handout
- Keywords
- physical activity, physical inactivity, PAD, Diabetes, High blood pressure, High cholesterol, Smoking
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity, Sedentary Behavior, Diabetes Mellitus, Hypertension, Hypercholesterolemia, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagesOther
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 CallsOther
Participants may receive a telephone call every two weeks for one month followed by once per month for two months.
HandoutOther
Handout includes information specific to participant's condition and ways to promote an active lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Text Messages; Other: Phone Calls; Other: Handout |
| Control Group | Active comparator | Participants will receive a handout with information on PAD and physical activity. Receives: Other: Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity
All participants will use a pedometer. Mean change will be measured based on steps per day.
Measured: Change from Baseline to 3 Months
Secondary outcomes (2)
Change in Exercise Behavior
Change will be measured using the Exercise Behaviors Survey.
Measured: 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.
Measured: Change from Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Tracie C. Collins, MD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622282
- Sponsor's protocol ID
- STUDY00003190
- Other IDs
- R56AG047590
- Status last verified
- Feb 2017
- First submitted
- 2 Dec 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31453076
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Promote Walking Among Latino Adults at Risk for PAD
- ClinicalTrials.gov ID
- NCT02622282
- Acronym / sponsor ID
- STUDY00003190
- Conditions
- Peripheral Arterial Disease
- Keywords
- physical activity, physical inactivity, PAD, Diabetes, High blood pressure, High cholesterol, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Text Messages, Other: Phone Calls, Other: HandoutParticipants 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 | Active comparator | Other: HandoutParticipants will receive a handout with information on PAD and physical activity. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessagesText messages will be sent one time per day. Text messages will include messages to motivate and inform participants on the importance of walking. | Other | Experimental Group |
| Phone CallsParticipants may receive a telephone call every two weeks for one month followed by once per month for two months. | Other | Experimental Group |
| HandoutHandout includes information specific to participant's condition and ways to promote an active lifestyle. | Other | Control Group, Experimental Group |
Primary outcome
Change in Physical Activity
Time frame: Change from Baseline to 3 Months
All participants will use a pedometer. Mean change will be measured based on steps per day.
2 secondary outcomes
Change in Exercise Behavior
Time frame: Change from Baseline to 3 Months
Change in Quality of Life
Time frame: Change from Baseline to 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 31453076Collins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracie C. Collins, MD, MPH principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messages, Phone Calls and Handout in people with Peripheral Arterial Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity (time frame: Change from Baseline to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02622282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.