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Activity-Aware Prompting to Improve Medication Adherence in Heart Failure Patients

Primary Purpose

Heart Failure, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prompting
Sponsored by
Washington State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have a diagnosis of HF and recently hospitalized for HF exacerbation
  • age ≥ 21 years;
  • live independently (not in an institutional setting); and
  • willing to carry the smartphone throughout the day.

Exclusion Criteria:

  • any serious co-morbidities (e.g. malignancy, neurological disorder),
  • impaired cognition,
  • inability to understand, read, write, or speak English or Spanish
  • major or uncorrected hearing or vision loss.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Medication adherence rate
    The Russell's adherence score will be used to measure medication adherence rate. A 3-hour window centered on the prescribed dosing time will be considered. A dose taken within this time window will be given a full score for that dosing time; a dose taken outside the window but within a 6 hour window will be given a half score for that dosing time; and missed doses will receive a score of 0. Each participant will be assigned a score from 0.0 to 1.0 for each day. The scores for each subject will be averaged to obtain weekly adherence rates. The overall adherence rate will be computed by taking an average other the entire study period.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 22, 2019
    Last Updated
    April 25, 2023
    Sponsor
    Washington State University
    Collaborators
    University of California, Irvine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04152031
    Brief Title
    Activity-Aware Prompting to Improve Medication Adherence in Heart Failure Patients
    Official Title
    Activity-Aware Prompting to Improve Medication Adherence in Heart Failure Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    October 20, 2016 (Actual)
    Primary Completion Date
    August 5, 2019 (Actual)
    Study Completion Date
    August 5, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington State University
    Collaborators
    University of California, Irvine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The long-term objective of this project is to improve human health and impact health care delivery by developing intelligent technologies that aid with health monitoring and intervention. The immediate objective of this project is to design, evaluate and validate machine learning-based software algorithms that recognize daily activities, provide activity-aware medicine reminder interventions and provide insights on intervention timings that yield successful compliance. The investigators hypothesize that many individuals with needs for medicine intervention can be more compliant with their medicine regimen if prompts are provided at the right times and in the right context. The investigators plan to accomplish these objectives by 1) enhancing and validating software algorithms that recognize daily activities and activity transitions, 2) developing and validating activity-aware medicine prompting interventions for mobile devices, and 3) designing technologies to analyze medicine reminder successes and failures. The proposed work will partner real-time methodologies for validation and algorithmic development with smart phone data, utilize novel activity discovery algorithms, and employ activity recognition and prediction algorithms in the development of activity-aware prompting.
    Detailed Description
    The investigators hypothesize that many individuals with needs for medicine intervention can be more compliant with their medicine regimen if prompts are provided at the right times and in the right context. They will validate the hypothesis by designing and evaluating machine learning-based software algorithms that recognize daily activities, provide activity-aware medicine reminder interventions and provide insights on intervention timings that yield successful compliance. The first aim of the project is to expand and validate software algorithms that recognize daily activities and activity transitions with mobile devices. The hypothesis is that daily behavior contexts can be characterized and tracked with minimal user input using machine learning combined with automated activity discovery. In earlier work, the investigators had demonstrated the success of our algorithms in smart homes. In this project, they propose to adapt the techniques for mobile devices. The second aim of the project is to develop activity-sensitive medicine prompting and assess the impact of activity-sensitive prompting on the primary outcome of medication adherence rates and the secondary outcome of quality of life. To this end, this goal can be decomposed into two tasks including (a) developing activity-sensitive prompting; (b) assessing the impact of activity-sensitive prompting on patient outcomes. The investigators will combine an activity prompting interface with activity recognition to deliver prompts in contexts with demonstrated success. Finally, in the third aim, the investigators design machine learning algorithms to analyze medicine reminder success and failure situations. They hypothesize that machine learning techniques can be used to automatically predict prompt compliance by using computer algorithms to learn how to distinguish successful from unsuccessful prompt situations. In their approach, the investigators utilize sensor data to analyze daily behavior and link behavior context with medicine adherence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Cardiovascular Diseases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Prompting
    Intervention Description
    Participants receive medication reminders on a smartphone. The reminders are generated through machine learning algorithms that automate the process of medication prompting according to successful medication contexts that occurred in the past.
    Primary Outcome Measure Information:
    Title
    Medication adherence rate
    Description
    The Russell's adherence score will be used to measure medication adherence rate. A 3-hour window centered on the prescribed dosing time will be considered. A dose taken within this time window will be given a full score for that dosing time; a dose taken outside the window but within a 6 hour window will be given a half score for that dosing time; and missed doses will receive a score of 0. Each participant will be assigned a score from 0.0 to 1.0 for each day. The scores for each subject will be averaged to obtain weekly adherence rates. The overall adherence rate will be computed by taking an average other the entire study period.
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: have a diagnosis of HF and recently hospitalized for HF exacerbation age ≥ 21 years; live independently (not in an institutional setting); and willing to carry the smartphone throughout the day. Exclusion Criteria: any serious co-morbidities (e.g. malignancy, neurological disorder), impaired cognition, inability to understand, read, write, or speak English or Spanish major or uncorrected hearing or vision loss.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not expect to share the data for this feasibility study. We, however, consider any requests for data access from other investigators. Those requesting the data will provide a data-sharing agreement to protect the participant's privacy and will receive only de-identified data.

    Learn more about this trial

    Activity-Aware Prompting to Improve Medication Adherence in Heart Failure Patients

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