NCT02454660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
Last Updated

April 11, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

May 12, 2015

Last Update Submit

April 7, 2017

Conditions

Medication Non-adherence

Keywords

adherencehypertensionmobile technologyintervention

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence (Proportion Days Covered (PDC)) assessed by administrative insurance records

    A measure of Proportion Days Covered (PDC) and is assessed administrative insurance records

    2 years

Secondary Outcomes (3)

  • Self-reported medication adherence assessed via a questionnaire

    baseline, 3 months and 9 months

  • Pill bottle openings (how often medication was taken) assessed by records from pill bottle caps (MEMS readers)

    9 months

  • Medication Beliefs assessed via a questionnaire

    baseline, 3 months and 9 months

Study Arms (2)

SMS (Text messaging)

EXPERIMENTAL

This group will receive text messages during their entire enrollment period in the study.

Behavioral: SMS (Text messages)

No SMS (No text messages)

NO INTERVENTION

This group will not receive text messages during their entire enrollment period in the study.

Interventions

SMS (Text messages)BEHAVIORAL

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.

SMS (Text messaging)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan College of Pharmacy

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (12)

  • Lawn S, Schoo A. Supporting self-management of chronic health conditions: common approaches. Patient Educ Couns. 2010 Aug;80(2):205-11. doi: 10.1016/j.pec.2009.10.006.

    PMID: 19931372BACKGROUND

  • Coleman MT, Newton KS. Supporting self-management in patients with chronic illness. Am Fam Physician. 2005 Oct 15;72(8):1503-10.

    PMID: 16273817BACKGROUND

  • Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

    PMID: 16079372BACKGROUND

  • 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

    BACKGROUND

  • Hill MN, Miller NH, Degeest S; American Society of Hypertension Writing Group; Materson BJ, Black HR, Izzo JL Jr, Oparil S, Weber MA. Adherence and persistence with taking medication to control high blood pressure. J Am Soc Hypertens. 2011 Jan-Feb;5(1):56-63. doi: 10.1016/j.jash.2011.01.001.

    PMID: 21320699BACKGROUND

  • Munger MA, Van Tassell BW, LaFleur J. Medication nonadherence: an unrecognized cardiovascular risk factor. MedGenMed. 2007 Sep 19;9(3):58.

    PMID: 18092064BACKGROUND

  • Vrijens B, Vincze G, Kristanto P, Urquhart J, Burnier M. Adherence to prescribed antihypertensive drug treatments: longitudinal study of electronically compiled dosing histories. BMJ. 2008 May 17;336(7653):1114-7. doi: 10.1136/bmj.39553.670231.25. Epub 2008 May 14.

    PMID: 18480115BACKGROUND

  • Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.

    PMID: 18425859BACKGROUND

  • Marx G, Witte N, Himmel W, Kuhnel S, Simmenroth-Nayda A, Koschack J. Accepting the unacceptable: medication adherence and different types of action patterns among patients with high blood pressure. Patient Educ Couns. 2011 Dec;85(3):468-74. doi: 10.1016/j.pec.2011.04.011. Epub 2011 May 19.

    PMID: 21600724BACKGROUND

  • 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

    BACKGROUND

  • Elliott RA, Shinogle JA, Peele P, Bhosle M, Hughes DA. Understanding medication compliance and persistence from an economics perspective. Value Health. 2008 Jul-Aug;11(4):600-10. doi: 10.1111/j.1524-4733.2007.00304.x. Epub 2008 Jan 8.

    PMID: 18194403BACKGROUND

  • Vervloet M, Linn AJ, van Weert JC, de Bakker DH, Bouvy ML, van Dijk L. The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J Am Med Inform Assoc. 2012 Sep-Oct;19(5):696-704. doi: 10.1136/amiajnl-2011-000748. Epub 2012 Apr 25.

    PMID: 22534082BACKGROUND

MeSH Terms

Conditions

Medication AdherenceHypertension

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Karen Farris, PhD

    Univerity of Michigan, College of Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Charles R. Walgreen Professor of Pharmacy Administration

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

November 4, 2016

Study Completion

November 4, 2016

Last Updated

April 11, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)