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Social Engagement Strategies to Improve Medication Adherence

Primary Purpose

Diabetes, Atherosclerosis Cardiovascular Disease, Congestive Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Network Feedback
Private Feedback
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Division Of General Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Private Feedback

Social Network Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Quality of Life measured by PROMIS-29
Assessed using PROMIS-29 survey.
Use of Technology for Health assessed by a short questionnaire
Patients will be asked whether they use tablets, smartphones, or other mobile technology.
Change of diet composition assessed by a dietary questionnaire
A short dietary questionnaire will be used to assess fruit, vegetable, fat, fiber, and sweetened beverage intake. For pragmatic reasons, longer food frequency questionnaire and 24 hour dietary recalls will be avoided because they may be too time consuming to complete.
Change of physical activity assessed using items from IPAQ-S
Investigators will measure frequency, duration and intensity of patient's physical activity using items from the International Physical Activity Questionnaire short form (IPAQ-S).
Change of depressive symptoms assessed using CES-D survey
Investigators will measure depressive symptoms using the CES-D, a validated scale based on the diagnostic criteria for major depressive disorder.
Change of medical history assessed using NHANES survey
Investigators will use questions from the NHANES
Change of smoking behavior assessed using the California Tobacco Survey
Investigators will use measures adapted from the California Tobacco Survey. During follow-up, investigators will ask about smoking cessation, quit attempts, reduction in daily
Change of self-efficacy and motivation assessed using PAM instrument
Investigators will assess self-efficacy, outcome expectancy, motivation, and patient activation. Patient activation will be assessed with the Patient Activation Measure (PAM) (see Reddy et al, JGIM 2017)
Change of social support usages assessed by MSPSS instrument
Investigators will measure social support with the Multidimensional Scale of Perceived Social Support (MSPSS) instrument.
Program Acceptability assessed by a random sub-sample of interviews
After the 12-week period, a random sub-sample of participants from both arms will be interviewed to measure the study's acceptability.

Full Information

First Posted
October 26, 2018
Last Updated
January 13, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03734887
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Inability to complete enrollment caused by COVID-19 and underpowered to conduct analysis
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Atherosclerosis Cardiovascular Disease, Congestive Heart Failure, Poor Medication Adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Private Feedback
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Social Network Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Network Feedback
Intervention Description
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
Intervention Name(s)
Private Feedback
Intervention Description
Participant will receive medication adherence feedback from a pharmacist at the start of the study.
Primary Outcome Measure Information:
Title
Change of Medication Adherence Rate
Description
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.
Time Frame
2 weeks, 4 weeks, 6 week, 8 weeks, 10 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life measured by PROMIS-29
Description
Assessed using PROMIS-29 survey.
Time Frame
Baseline, 12 weeks
Title
Use of Technology for Health assessed by a short questionnaire
Description
Patients will be asked whether they use tablets, smartphones, or other mobile technology.
Time Frame
Baseline
Title
Change of diet composition assessed by a dietary questionnaire
Description
A short dietary questionnaire will be used to assess fruit, vegetable, fat, fiber, and sweetened beverage intake. For pragmatic reasons, longer food frequency questionnaire and 24 hour dietary recalls will be avoided because they may be too time consuming to complete.
Time Frame
Baseline, 12 weeks
Title
Change of physical activity assessed using items from IPAQ-S
Description
Investigators will measure frequency, duration and intensity of patient's physical activity using items from the International Physical Activity Questionnaire short form (IPAQ-S).
Time Frame
Baseline, 12 weeks
Title
Change of depressive symptoms assessed using CES-D survey
Description
Investigators will measure depressive symptoms using the CES-D, a validated scale based on the diagnostic criteria for major depressive disorder.
Time Frame
Baseline, 12 weeks
Title
Change of medical history assessed using NHANES survey
Description
Investigators will use questions from the NHANES
Time Frame
Baseline, 12 weeks
Title
Change of smoking behavior assessed using the California Tobacco Survey
Description
Investigators will use measures adapted from the California Tobacco Survey. During follow-up, investigators will ask about smoking cessation, quit attempts, reduction in daily
Time Frame
Baseline, 12 weeks
Title
Change of self-efficacy and motivation assessed using PAM instrument
Description
Investigators will assess self-efficacy, outcome expectancy, motivation, and patient activation. Patient activation will be assessed with the Patient Activation Measure (PAM) (see Reddy et al, JGIM 2017)
Time Frame
Baseline, 12 weeks
Title
Change of social support usages assessed by MSPSS instrument
Description
Investigators will measure social support with the Multidimensional Scale of Perceived Social Support (MSPSS) instrument.
Time Frame
Baseline, 12 Weeks
Title
Program Acceptability assessed by a random sub-sample of interviews
Description
After the 12-week period, a random sub-sample of participants from both arms will be interviewed to measure the study's acceptability.
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Mangione, MD,MSPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Division Of General Internal Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
CLA Health. Provider Information - MyMeds 2017; https://www.uclahealth.org/mymeds/providers. Accessed July 9, 2017, 2017
Results Reference
background
PubMed Identifier
28029924
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.
Results Reference
background
PubMed Identifier
21389250
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.
Results Reference
background
PubMed Identifier
16079372
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.
Results Reference
background
PubMed Identifier
26831740
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.
Results Reference
background
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.
Results Reference
background
Citation
Pew Research Center. Pew Research Center: Mobile Fact Sheet. 2017; http://www.pewinternet.org/fact-sheet/mobile/. Accessed July 9, 2017, 2017.
Results Reference
background

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Social Engagement Strategies to Improve Medication Adherence

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