Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence

NCT ID: NCT06066541

Last Updated: 2025-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Medicare Advantage beneficiaries ages 65-79 and insured by Humana with at least two unique fills of hypertension medication within the 2023 calendar year and adherence level between 60 and 85% will be identified using Humana Medicare Advantage claims data. Individuals meeting these inclusion criteria will be included and, with an institutional review board approved waiver of informed consent, will be randomized to one of 6 mailed messages or control (no message). The messages will be sent by Humana and use different behavioral techniques (social norms, messenger effects, and/or processing fluency) providing their medication refill score. Humana will send a second message within 60 days of the first message noting any changes in the refill score.

The primary outcome will be the average end-of-year adherence in each arm. A secondary outcome will be the proportion of study participants with end-of-year adherence greater than or equal to 80%. The study team's hypothesis is that messages using dynamic social norms, messenger effects, and processing fluency in combination will more effectively increase average end-of-year adherence level compared to usual care.

Humana will conduct all study participant outreach and data analyses, which will be performed using routinely collected insurance claims data. Regulatory oversight is conducted using Humana's centralized institutional review board (IRB) of record. The work completed by Humana study staff is funded by Humana, Inc.

Dr. Choudhry and his colleagues (including subaward recipients ideas42 and Tuck School of Business at Dartmouth) will provide technical and subject matter expertise related to study research design and implementation, protocol design, statistical analysis, publication (abstract, poster, manuscript) preparation and/or review, and assistance throughout the peer review process including revisions and additional analyses if necessary for this project. The work completed by study staff at Brigham and Women's Hospital, ideas42, and Tuck School of Business at Dartmouth is funded by NIA.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Adherence Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Scorecard

Participants randomized to this arm will receive a scorecard from Humana reporting patients' medication adherence using a "refill score." Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.

Group Type ACTIVE_COMPARATOR

Scorecard

Intervention Type BEHAVIORAL

Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."

Scorecard + Social norms

Participants randomized to this arm will receive the Arm 1 scorecard plus dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores). Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.

Group Type EXPERIMENTAL

Scorecard

Intervention Type BEHAVIORAL

Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."

Social norms

Intervention Type BEHAVIORAL

Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).

Scorecard + Messenger effects

Participants randomized to this arm will receive the Arm 1 scorecard, coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.

Group Type EXPERIMENTAL

Scorecard

Intervention Type BEHAVIORAL

Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."

Messenger effects

Intervention Type BEHAVIORAL

Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.

Processing fluency

Participants randomized to this arm will receive a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring." Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.

Group Type EXPERIMENTAL

Processing fluency

Intervention Type BEHAVIORAL

Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."

Processing fluency + Social norms

Participants randomized to this arm will receive the Arm 4 processing fluency scorecard plus dynamic social norms messaging. Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.

Group Type EXPERIMENTAL

Social norms

Intervention Type BEHAVIORAL

Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).

Processing fluency

Intervention Type BEHAVIORAL

Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."

Processing fluency + Messenger effects

Participants randomized to this arm will receive the Arm 4 processing fluency scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication. Two messages will be sent during the intervention: The first message will contain the baseline refill score. The second message will note any changes in the refill score.

Group Type EXPERIMENTAL

Messenger effects

Intervention Type BEHAVIORAL

Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.

Processing fluency

Intervention Type BEHAVIORAL

Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."

Usual care

Participants randomized to this arm will not receive any mailed message.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scorecard

Participants will be mailed a scorecard from Humana reporting patients' medication adherence using a "refill score."

Intervention Type BEHAVIORAL

Social norms

Participants will be mailed a dynamic social norms messaging (noting the proportion of Humana members improving their medication refill scores).

Intervention Type BEHAVIORAL

Messenger effects

Participants will be mailed a scorecard coming from the trusted messenger of a Humana-identified pharmacist taking the same medication.

Intervention Type BEHAVIORAL

Processing fluency

Participants will be mailed a modified scorecard increasing processing fluency through a visual metaphor of "closing the ring."

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Medicare Advantage beneficiary insured by Humana
* Between the ages of 65 and 79
* Having at least two unique fills of any class of hypertension medication within the calendar year (2023).
* Adherence level (as measured by the proportion of days covered \[PDC\] metric) between 60% and 85%

Exclusion Criteria

* Beneficiaries in plans which, per contractual agreements, privacy policies and rules, or legal requirements, do not participate in research
Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Humana Inc.

INDUSTRY

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Niteesh K. Choudhry, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ted Robertson, MPA

Role: PRINCIPAL_INVESTIGATOR

Ideas42

Punam Keller, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

Tuck School of Business at Dartmouth

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Humana, Inc.

Louisville, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Keller P, Robertson T, Kao LS, Li Y, Merrell B, Chung L, Boudreau E, James A, Esterly L, Hanken K, Choudhry NK. Incorporating Behavioral Science in Medication Adherence Communication: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510162. doi: 10.1001/jamanetworkopen.2025.10162.

Reference Type DERIVED
PMID: 40366654 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30AG064199

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023p002222

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile Health Management of Hypertension
NCT05856955 NOT_YET_RECRUITING NA
Behavioral Study to Control Blood Pressure
NCT01035554 COMPLETED PHASE2/PHASE3