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Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

6 september 2018 uppdaterad av: Mintu Turakhia, Stanford University

Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

This study evaluates a smartphone-based cardiac rehabilitation program in adults with coronary artery disease. Half of patients will participate in a smartphone-based cardiac rehabilitation program while the other half will receive standard-of-care.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

Cardiac rehabilitation as a means to improve lifestyle-based risk factor modification, remains poorly prescribed and utilized, often due to the lack of access to programs, poor insurance coverage, cost, or patient or physician motivational factors. Low-cost solutions that can improve patient adherence to medications, risk factor reduction, and exercise could improve cardiovascular outcomes and cost-effectiveness compared to current care models.

Studietyp

Interventionell

Inskrivning (Faktisk)

63

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • Stanford, California, Förenta staterna, 94305
        • Stanford Healthcare

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion criteria:

I. ≥ 18 years of age

II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).

III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at least 3 months following discharge

IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an active phone number and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. Wi-Fi internet capability is not a substitute for an active cellular data plan.

V. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

VI. Willing to have the mobile application installed on a smartphone and use it every day during the entire study period VII. Willing to provide oral confirmation indicating that he/she is currently not using a medication adherence application.

VIII. Ability to read and understand English.

Exclusion criteria:

Any potential participant who meets any of the following criteria will be excluded from participating in the study:

I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on opinion of site Principal Investigator (PI).

II. Current use of adherence tracking devices, electronic, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion.

a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion.

III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone. Co-morbidities that would preclude participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve replacement) IV. End-stage of one of the following: heart failure (using left ventricular assist device or listed for heart transplantation), renal disease, lung disease, liver disease.

V. Any condition with a life expectancy less than 3 months. VI. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator VII. Any other condition as determined by the PI.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: smartphone-based cardiac rehabilitation
The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
BrightHeart® has two components: smartphone mobile based application and a human coach. It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
Inget ingripande: Control
Standard-of-care alone.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Medication adherence
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
Baseline through End of Study visit - approximately 90 days per participant.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Medication adherence II
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence III
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
The PDC of each medication of the composite
Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence IV
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants with PDC ≥ 80% of each of the composite
Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence V
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Mean time from discharge to first fill
Baseline through End of Study visit - approximately 90 days per participant.
Medication persistence
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors I
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Serum LDL-C at End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors II
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors III
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors IV
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Change in body weight from baseline to End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors V
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VI
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VII
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Physical activity at End of Study (measured by a physical acitivity questionnaire)
Baseline through End of Study visit - approximately 90 days per participant.
Exploratory I: Rehospitalization
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
30-day rehospitalization for any reason
Baseline through End of Study visit - approximately 90 days per participant.
Exploratory II: Cardiovascular outcomes
Tidsram: Baseline through End of Study visit - approximately 90 days per participant.
Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days
Baseline through End of Study visit - approximately 90 days per participant.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Minang (Mintu) Turakhia, MD, Stanford University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 juli 2017

Primärt slutförande (Faktisk)

9 maj 2018

Avslutad studie (Faktisk)

17 augusti 2018

Studieregistreringsdatum

Först inskickad

16 juni 2017

Först inskickad som uppfyllde QC-kriterierna

30 juni 2017

Första postat (Faktisk)

5 juli 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 september 2018

Senast verifierad

1 september 2018

Mer information

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Kliniska prövningar på Kranskärlssjukdom

Kliniska prövningar på BrightHeart®

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