Clinical trial NCT03734887: Social Engagement Strategies to Improve Medication Adherence
Official title: Social Engagement Strategies to Improve Medication Adherence Among Older Adults in Los Angeles Count Participating in MyMeds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Atherosclerosis Cardiovascular Disease
Congestive Heart Failure
Poor Medication Adherence
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Medication Adherence Rate
timeFrame: 2 weeks, 4 weeks, 6 week, 8 weeks, 10 weeks, and 12 weeks
Secondary outcomes:
measure: Change in Quality of Life measured by PROMIS-29
timeFrame: Baseline, 12 weeks
measure: Use of Technology for Health assessed by a short questionnaire
timeFrame: Baseline
measure: Change of diet composition assessed by a dietary questionnaire
timeFrame: Baseline, 12 weeks
measure: Change of physical activity assessed using items from IPAQ-S
timeFrame: Baseline, 12 weeks
measure: Change of depressive symptoms assessed using CES-D survey
timeFrame: Baseline, 12 weeks
measure: Change of medical history assessed using NHANES survey
timeFrame: Baseline, 12 weeks
measure: Change of smoking behavior assessed using the California Tobacco Survey
timeFrame: Baseline, 12 weeks
measure: Change of self-efficacy and motivation assessed using PAM instrument
timeFrame: Baseline, 12 weeks
measure: Change of social support usages assessed by MSPSS instrument
timeFrame: Baseline, 12 Weeks
measure: Program Acceptability assessed by a random sub-sample of interviews
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Division Of General Internal Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Carol Mangione, MD,MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: CLA Health. Provider Information - MyMeds 2017; https://www.uclahealth.org/mymeds/providers. Accessed July 9, 2017, 2017
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Pew Research Center. Pew Research Center: Mobile Fact Sheet. 2017; http://www.pewinternet.org/fact-sheet/mobile/. Accessed July 9, 2017, 2017.