Social Engagement Strategies to Improve Medication Adherence

NCT ID: NCT03734887

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2022-07-01

Brief Summary

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In this pilot study, investigators, in partnership with Resource Centers for Minority Aging Research (RCMAR) mentorship team and the MyMeds program, will enroll patients from MyMeds with diabetes, atherosclerotic cardiovascular disease, or congestive heart failure with poor medication adherence (medication adherence percentage\<80% for statin or antihypertensive therapy) who report having a least one loved one or friend (e.g., spouse) whom they consider to be invested in their health, and with whom they would be willing to share focused medical information about medication adherence in the form of text messages. Participants will be randomized into either a private feedback arm or social network arm. In the private feedback arm, participants will only receive private consultations from a pharmacist regarding their medication adherence rates. In the social network arm, participants and their chosen loved one or friend will receive bi-weekly feedback text messages regarding the participant's medication adherence. Investigators will evaluate the effects of this social network intervention on medication adherence and examine the program's acceptability among study participants. This proposal is innovative because it leverages social networks-largely unused in medical care-for health improvement.

Detailed Description

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MyMeds (Managing Your Medication for Education and Daily Support) is an innovative care improvement program that embeds pharmacists into 27 University of California, Los Angeles (UCLA) primary care practices with the goals of (1) simplifying and reconciling medication regimens; (2) identifying strategies to improve adherence; and (3) reducing patient costs with generic substitutions and drug assistance programs. This program targets complex older adults and adults with poorly-controlled diabetes of all ages, and has reached more than 7,000 patients since its implementation in 2012. In an evaluation of over 700 older adults (≥65 years-old) who received a MyMeds consultation, investigators showed that the program reduced hospitalizations. In another evaluation that included adults of all ages, investigators showed that MyMeds reduced emergency department use (21%), systolic blood pressure (4 mmHg), and HbA1c (0.8%). However, a major underused resource in efforts to improve the health of complex adults targeted by MyMeds is their social network. Social networks are cost-free and highly influential social relationships and interactions that influence behavior and conversely are influenced by a patient's behavior. Patients spend vastly more time interacting within their social networks than they do interacting with healthcare providers, and patients often share health information with supportive members of their social network. These interactions, which are often substantial in quantity, could be designed to beneficially influence a patient's ability to create and sustain healthy behavior change. Medication nonadherence, in particular, increases morbidity, mortality, and healthcare costs in patients with chronic disease, but the private (rather than public) nature of taking medications limits the exposure of medication nonadherence to influence from the social network. An appropriately designed social network intervention can shift the dynamic, and MyMeds is an ideal setting for this type of intervention because it has robust infrastructure for identifying eligible patients, enrolling them in a pilot study, and measuring outcomes.

In this pilot study, investigators, in partnership with RCMAR mentorship team and the MyMeds program, will enroll patients from MyMeds with diabetes, atherosclerotic cardiovascular disease, or congestive heart failure with poor medication adherence (medication adherence percentage\<80% for statin or antihypertensive therapy) who report having a least one loved one or friend (e.g., spouse) whom they consider to be invested in their health, and with whom they would be willing to share focused medical information about medication adherence in the form of text messages. Participants will be randomized into either a private feedback arm or social network arm. In the private feedback arm, participants will only receive private consultations from a pharmacist regarding their medication adherence rates. In the social network arm, participants and their chosen loved one or friend will receive bi-weekly feedback text messages regarding the participant's medication adherence. Investigators will evaluate the effects of this social network intervention on medication adherence and examine the program's acceptability among study participants. This proposal is innovative because it leverages social networks-largely unused in medical care-for health improvement.

Conditions

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Diabetes Atherosclerosis Cardiovascular Disease Congestive Heart Failure Poor Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention will enroll 70 patients over a 6-month period. Investigators will provide each patient with a smart pill bottle to sync medication use data with their phones and provide real-time data about adherence to study staff. After completing a baseline survey, investigators will confirm eligibility (including confirmation of loved ones' willingness to receive text messages), and randomize eligible patients to one of the two study arms. With synced data from the smart pill box, investigators will provide biweekly feedback about adherence in the form of a brief text message, including a comparison to the patient's adherence in the preceding week. Biweekly feedback will be provided for 12 weeks and semi-structured interviews will be performed among a random subsample of participants afterward.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Private Feedback

Participants will receive a smart pill bottle that will collect data on their medication usage and provide real-time data about adherence to study staff. Study staff will provide participants with private feedback about adherence in the form of meeting with a pharmacist. Feedback will be provided at the start of the study. A semi-structured interviews will be performed among a random sub-sample of participants afterwards.

Group Type ACTIVE_COMPARATOR

Private Feedback

Intervention Type BEHAVIORAL

Participant will receive medication adherence feedback from a pharmacist at the start of the study.

Social Network Intervention

Participants will receive the same treatment as the Private Feedback arm but they will additionally have Social Network Feedback. A biweekly feedback text messages will be sent to both the participant and a designated loved-one or friend of the participants for 12 weeks.

Group Type EXPERIMENTAL

Social Network Feedback

Intervention Type BEHAVIORAL

Social networks are cost-free and highly influential social relationships and interactions that influence behavior and conversely are influenced by a patient's behavior. In addition to receiving a private text message regarding their medication adherence rate, participant's feedback will also be shared to a loved-one or friend that the participant is willing to share medical information with.

Private Feedback

Intervention Type BEHAVIORAL

Participant will receive medication adherence feedback from a pharmacist at the start of the study.

Interventions

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Social Network Feedback

Social networks are cost-free and highly influential social relationships and interactions that influence behavior and conversely are influenced by a patient's behavior. In addition to receiving a private text message regarding their medication adherence rate, participant's feedback will also be shared to a loved-one or friend that the participant is willing to share medical information with.

Intervention Type BEHAVIORAL

Private Feedback

Participant will receive medication adherence feedback from a pharmacist at the start of the study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age \> 50 years
* non-adherence to a statin or antihypertensive medication in the preceding 3 months
* access to a phone with text messaging capabilities, Bluetooth connections and internet access.
* at least one loved-one or friend with whom adherence feedback can be shared
* ability to speak English or Spanish

Exclusion Criteria

* Any recorded A1c values of \>6.5%
* ICD-9 billing codes of 250.xx
* Use of any antiglycemic medication
* Current or past participation in the Diabetes prevention Program prior to providing informed consent
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Carol Mangione

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carol Mangione, MD,MSPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Division Of General Internal Medicine

Los Angeles, California, United States

Site Status

Countries

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United States

References

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CLA Health. Provider Information - MyMeds 2017; https://www.uclahealth.org/mymeds/providers. Accessed July 9, 2017, 2017

Reference Type BACKGROUND

Asch DA, Rosin R. Engineering Social Incentives for Health. N Engl J Med. 2016 Dec 29;375(26):2511-3. doi: 10.1056/NEJMp1603978. No abstract available.

Reference Type BACKGROUND
PMID: 28029924 (View on PubMed)

Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9.

Reference Type BACKGROUND
PMID: 21389250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16079372 (View on PubMed)

Thakkar J, Kurup R, Laba TL, Santo K, Thiagalingam A, Rodgers A, Woodward M, Redfern J, Chow CK. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. JAMA Intern Med. 2016 Mar;176(3):340-9. doi: 10.1001/jamainternmed.2015.7667.

Reference Type BACKGROUND
PMID: 26831740 (View on PubMed)

Smith A. Pew Research Center: Americans and Text Messaging. 2011; http://www.pewinternet.org/2011/09/19/americans-and-text-messaging/. Accessed July 9, 2017, 2017.

Reference Type BACKGROUND

Pew Research Center. Pew Research Center: Mobile Fact Sheet. 2017; http://www.pewinternet.org/fact-sheet/mobile/. Accessed July 9, 2017, 2017.

Reference Type BACKGROUND

Other Identifiers

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2P30AG021684-16

Identifier Type: NIH

Identifier Source: org_study_id

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