- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02783287
The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The Impact of Text Messaging on Medication Adherence and Exercise Regimen among Post-Myocardial Infarction Patients includes two single-center randomized control trials to assess the impact of text message reminds on adherence to medications and exercise regimen in patients recently discharged from the hospital after MI.
Recruitment conducted at Cambridge Cardiac Rehabilitation in Ontario, Canada for both the medication adherence and exercise trial. Potential study subjects are evaluated for inclusion and exclusion criteria, give written informed consent, and are randomized, in a 1:1 ratio, to either intervention or usual care (control).
Patients randomized to the intervention arm in the medication adherence trial receive an automated text message once per day at the time they are prescribed to take their medication. The text message does not contain any personal or pharmacological information.
Patients randomized to the intervention arm in the exercise adherence trial receive four text messages per day at 7:30 am, 12:00 pm, 6:00 pm, and 9:00 pm, reminding them to exercise for 30 minutes per day as per their health care provider.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Post-MI hospital discharge within 2 weeks
- Enrolled in cardiac rehabilitation
- Prescribed anti-platelets, beta-blockers, ACE-inhibitors or ARBs, and/or statins on 1x/day regimen (for medication adherence trial)
- Prescribed exercise regimen (for exercise trial)
- Ability to read and write English
- Possession of a cell phone with text messaging capability
Exclusion Criteria:
- Age < 18
- Incarcerated individuals
- Unable to read and write English
- Not in possession of a cell phone
- Patients prescribed medication regimen > 1x/day
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Medication text message
Once daily text message reminder.
|
Patients randomized to this arm receive one text message per day (at the scheduled time) reminding them to take their medication.
|
|
Eksperimentell: Exercise text message
4x daily text message reminder.
|
Patients randomized to this arm receive 4 daily text messages reminding them to exercise for 30 minutes per day.
|
|
Ingen inngripen: Usual care, medication adherence
Usual care for medication adherence.
|
|
|
Ingen inngripen: Usual care, exercise regimen
Usual care for exercise regimen.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Medication adherence
Tidsramme: 12 months
|
Average medication adherence over 12 months after randomization, assessed with self-reported logs
|
12 months
|
|
Exercise frequency
Tidsramme: 12 months
|
Average frequency of exercise over 12 months after randomization, assessed with self-reported logs
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise duration
Tidsramme: 12 months
|
Average duration of exercise assessed by BRUCE protocol
|
12 months
|
|
Full medication adherence
Tidsramme: 12 months
|
Average medication adherence over 12 months greater than .80
|
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Niteesh K Choudhry, MD, PhD, Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20980
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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