Social Engagement Strategies to Improve Medication Adherence

NCT03734887 | Terminated

• 1 other identifier: 2P30AG021684-16
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Atherosclerosis Cardiovascular Disease; Congestive Heart Failure; Poor Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Change of Medication Adherence Rate

  Rate at which participant is taking their medication. Outcome would be measured bi-weekly using a smart pill bottle and syncing data using blue-tooth capable phones.

  2 weeks, 4 weeks, 6 week, 8 weeks, 10 weeks, and 12 weeks

Secondary Outcomes (10)

• Change in Quality of Life measured by PROMIS-29

  Baseline, 12 weeks

• Use of Technology for Health assessed by a short questionnaire

  Baseline

• Change of diet composition assessed by a dietary questionnaire

  Baseline, 12 weeks

• Change of physical activity assessed using items from IPAQ-S

  Baseline, 12 weeks

• Change of depressive symptoms assessed using CES-D survey

  Baseline, 12 weeks

Study Arms (2)

Private Feedback

ACTIVE COMPARATOR

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.

Behavioral: Private Feedback

Social Network Intervention

EXPERIMENTAL

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.

Behavioral: Social Network Feedback; Behavioral: Private Feedback

Interventions

Social Network Feedback 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.

Social Network Intervention

Private Feedback BEHAVIORAL

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

Private Feedback; Social Network Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Division Of General Internal Medicine

Los Angeles, California, 90024, United States

Location

Related Publications (7)

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

  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.

  PMID: 28029924 BACKGROUND

• 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.

  PMID: 21389250 BACKGROUND

• 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: 16079372 BACKGROUND

• 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.

  PMID: 26831740 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carol Mangione, MD,MSPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 8, 2018
• Study Start: October 31, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)