NCT02622282

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

December 2, 2015

Last Update Submit

February 1, 2017

Conditions

Keywords

physical activityphysical inactivityPADDiabetesHigh blood pressureHigh cholesterolSmoking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in Exercise Behavior

    Change from Baseline to 3 Months

  • Change in Quality of Life

    Change from Baseline to 3 Months

Study Arms (2)

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.

Other: Text MessagesOther: Phone CallsOther: Handout

Control Group

ACTIVE COMPARATOR

Participants will receive a handout with information on PAD and physical activity.

Other: Handout

Interventions

Text messages will be sent one time per day. Text messages will include messages to motivate and inform participants on the importance of walking.

Experimental Group

Participants may receive a telephone call every two weeks for one month followed by once per month for two months.

Experimental Group
HandoutOTHER

Handout includes information specific to participant's condition and ways to promote an active lifestyle.

Control GroupExperimental Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU School of Medicine - Wichita

Wichita, Kansas, 67214, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Peripheral Arterial DiseaseMotor ActivitySedentary BehaviorDiabetes MellitusHypertensionHypercholesterolemiaSmoking

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Tracie C. Collins, MD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations