- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02783287
The Impact of Text Messaging on Medication Adherence and Exercise Regimen Among Post-myocardial Infarction Patients
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Eksperimentel: 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 indgriben: Usual care, medication adherence
Usual care for medication adherence.
|
|
Ingen indgriben: Usual care, exercise regimen
Usual care for exercise regimen.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Niteesh K Choudhry, MD, PhD, Center for Healthcare Delivery Sciences, Brigham and Women's Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20980
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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