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Improving Adherence and Outcomes by Artificial Intelligence-Adapted Text Messages (AIM@BP)

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ClinicalTrials.gov Identifier: NCT02454660
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Karen Farris, PhD., University of Michigan

Brief Summary:
Uncontrolled hypertension is a major cause of morbidity and mortality and many patients fail to take their antihypertensive medication as prescribed. The investigators propose to use artificial intelligence (AI) to allow short message service (SMS or text messages) interventions to adapt to patients' adherence needs and substantially improve medication taking. The aims of the study are to: (1) develop AI methods for adaptive decision-making in human-centered environments and demonstrate the feasibility of the resulting AI-enhanced SMS medication adherence intervention, (2) demonstrate that the intervention can "learn" by adapting the SMS message stream according to patients' medication taking over time, and (3) examine potential intervention impact as measured by improvements in medication adherence and systolic blood pressures. The investigators will recruit 100 patients with uncontrolled hypertension and antihypertensive medication non-adherence. Adherence and other covariates will be measured via surveys at baseline, 3- and 6 months; blood pressures will be measured at baseline and 6 months. Participants will be given an electronic pill-bottle adherence monitor. Participants will receive SMS messages designed to motivate antihypertensive medication adherence. Message content and frequency will adapt automatically using AI algorithms designed to automatically optimize expected pill bottle opening. For Aim 1, the first 25 patients will be enrolled to develop and test alternative RL algorithms and fine-tune the system parameters. For Aim 2, the investigators will examine changes in the probability distribution over message-types and compare that distribution with patients' reasons for non-adherence reported at baseline. For Aim 3, the investigators will examine changes in self-reported medication non-adherence and blood pressure and automatically-reported pill bottle openings. This pilot study will establish the feasibility and potential impact of this novel approach to mobile health messaging for self-management support. The results will be used to support an R01 application for a larger and more definitive trial of intervention impacts.

Condition or disease Intervention/treatment Phase
Medication Non-adherence Behavioral: SMS (Text messages) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Improving Adherence and Outcomes by Artificial Intelligence-Adapted Text Messages
Actual Study Start Date : May 2015
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : November 4, 2016

Arm Intervention/treatment
Experimental: SMS (Text messaging)
This group will receive text messages during their entire enrollment period in the study.
Behavioral: SMS (Text messages)
Up to 1 text message a day. The artificial agent will determine whether to send a message each day. If it sends a message, it will also determine which of five message types to send.

No Intervention: No SMS (No text messages)
This group will not receive text messages during their entire enrollment period in the study.



Primary Outcome Measures :
  1. Medication Adherence (Proportion Days Covered (PDC)) assessed by administrative insurance records [ Time Frame: 2 years ]
    A measure of Proportion Days Covered (PDC) and is assessed administrative insurance records


Secondary Outcome Measures :
  1. Self-reported medication adherence assessed via a questionnaire [ Time Frame: baseline, 3 months and 9 months ]
    Medication adherence is collected at these time points and assessed via a questionnaire.

  2. Pill bottle openings (how often medication was taken) assessed by records from pill bottle caps (MEMS readers) [ Time Frame: 9 months ]
    proxy measure of how often medication was taken, assessed by records from pill bottle caps (MEMS readers)

  3. Medication Beliefs assessed via a questionnaire [ Time Frame: baseline, 3 months and 9 months ]
    A measurement of the patients beliefs about the medication they take will be collected at these time points and assessed via a questionnaire.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient must have Priority Health Care Health Insurance Coverage
  • Patient must have PDC of < 0.5 for anti-hypertensive medications

Exclusion Criteria:

  • No hypertension medicine currently taken
  • Patient doesn't text message (no cell phone) in an average week
  • No access to the internet
  • Patient has heart failure which makes it difficult to catch breath and move around
  • Patient uses artificial oxygen to breathe
  • Patient is currently under treatment for cancer
  • Patient currently has kidney disease that requires dialysis
  • Patient self reports a mental health diagnosis (from a health professional)
  • Patient reports having schizophrenia
  • Patient reports currently being treated bipolar disorder or manic-depressive illness or schizophrenia
  • Patients reports ever been diagnosed with dementia or Alzheimer's disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454660


Locations
United States, Michigan
University of Michigan College of Pharmacy
Ann Arbor, Michigan, United States, 48109
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Karen Farris, PhD Univerity of Michigan, College of Pharmacy

Publications:
NEHI. Thinking outside the pillbox: a system-wide approach to improving patient medication adherence for chronic disease. http://www.nehi.net/publications/44/thinking_outside_the_pillbox_a_systemwide_approach_to_improving_patient_medication_adherence_for_chronic_disease, Accessed 09 12 12
Sabate E - World Health Organization. Adherence to long-term therapies: evidence for action. 2003. http://apps.who.int/medicinedocs/en/d/Js4883e/, Accessed 09 12 12

Responsible Party: Karen Farris, PhD., Charles R. Walgreen Professor of Pharmacy Administration, University of Michigan
ClinicalTrials.gov Identifier: NCT02454660     History of Changes
Other Study ID Numbers: 1R21HS022336-01A1 ( U.S. AHRQ Grant/Contract )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Karen Farris, PhD., University of Michigan:
adherence
hypertension
mobile technology
intervention