NCT05766423

Brief Summary

This study is being conducted to adapt and pilot test a technology-enabled, primary care strategy for routinely monitoring medication use and adherence among older adults with multiple chronic conditions and polypharmacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 17, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

February 17, 2023

Results QC Date

March 18, 2025

Last Update Submit

June 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    Participants' medication adherence will be measured at about 2-4 weeks after their clinic visit using a validated self-report measure: ASK-12. The 12-item measure assesses general medication attitudes and beliefs across three domains: 1) inconvenience/forgetfulness, 2) treatment beliefs, and 3) behaviors. Response options range from "Strongly Disagree" to "Strongly Agree". Scores can range from 12-60 with higher scores representing greater barriers to adherence.

    About 2-4 Weeks

Secondary Outcomes (1)

  • Fidelity

    By the scheduled clinic visit (baseline)

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care includes: 1. The normal standard clinical practices at the participating practice. 2. No specific materials to promote PATTERN, and no additional materials that include adherence assessments or care alert notifications.

The PATTERN Intervention

ACTIVE COMPARATOR

The intervention components include: 1. An adherence assessment completed by participants ahead of a regularly scheduled clinic visit. 2. Care alert notifications directed to a nurse pool and/or member of the clinical care team.

Behavioral: The PATTERN Intervention

Interventions

The intervention components include: 1. An adherence assessment that requests patients to self-report via MyChart about their medication use. The assessment provides a link between the health center and the patient ahead of a regularly scheduled clinic visit. 2. Care alert notifications directed to a nurse pool and/or member of the clinical care team when a medication adherence related problem is identified by the adherence assessment. The alert will also include the type of problem the patient is experiencing (cognitive, psychological, medical, regiment, social and/or economic). Once they receive these alerts, the care team can then activate appropriate staff and/or resources to respond.

The PATTERN Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Each participant must:
  • Be an adult aged 65 or older
  • Speak English as their primary language
  • Have multiple chronic conditions
  • Be prescribed 8 or more medications
  • Be primarily responsible for administering own medication
  • Receive medical care at the participating primary care practice
  • Have access to the internet and an active email address
  • Be signed up for the patient portal (MyChart)

You may not qualify if:

  • No participant can:
  • Have severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Research Assistant Professor
Organization
Northwestern University

Study Officials

  • Allison Pack, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 13, 2023

Study Start

January 18, 2024

Primary Completion

August 15, 2024

Study Completion

August 15, 2024

Last Updated

June 11, 2025

Results First Posted

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations