- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02783287
The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Inget ingripande: Usual care, medication adherence
Usual care for medication adherence.
|
|
|
Inget ingripande: Usual care, exercise regimen
Usual care for exercise regimen.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Medication adherence
Tidsram: 12 months
|
Average medication adherence over 12 months after randomization, assessed with self-reported logs
|
12 months
|
|
Exercise frequency
Tidsram: 12 months
|
Average frequency of exercise over 12 months after randomization, assessed with self-reported logs
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exercise duration
Tidsram: 12 months
|
Average duration of exercise assessed by BRUCE protocol
|
12 months
|
|
Full medication adherence
Tidsram: 12 months
|
Average medication adherence over 12 months greater than .80
|
12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Niteesh K Choudhry, MD, PhD, Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20980
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .