- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02622282
Text Messaging to Promote Walking Among Latino Adults at Risk for Peripheral Arterial Disease
Text Messaging to Promote Walking Among Latino Adults at Risk for PAD
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Kansas
-
Wichita, Kansas, Forente stater, 67214
- KU School of Medicine - Wichita
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental Group
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.
|
Text messages will be sent one time per day.
Text messages will include messages to motivate and inform participants on the importance of walking.
Participants may receive a telephone call every two weeks for one month followed by once per month for two months.
Handout includes information specific to participant's condition and ways to promote an active lifestyle.
|
|
Aktiv komparator: Control Group
Participants will receive a handout with information on PAD and physical activity.
|
Handout includes information specific to participant's condition and ways to promote an active lifestyle.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Physical Activity
Tidsramme: Change from Baseline to 3 Months
|
All participants will use a pedometer.
Mean change will be measured based on steps per day.
|
Change from Baseline to 3 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Exercise Behavior
Tidsramme: Change from Baseline to 3 Months
|
Change will be measured using the Exercise Behaviors Survey.
|
Change from Baseline to 3 Months
|
|
Change in Quality of Life
Tidsramme: Change from Baseline to 3 Months
|
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tracie C. Collins, MD, MPH, University of Kansas Medical Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00003190
- R56AG047590 (U.S. NIH-stipend/kontrakt)
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