Gamification and Medication Adherence (GAME Adherence)

Gamification and Social Incentives to Augment Medication Adherence

A two-arm randomized controlled trial to evaluate whether a gamification intervention plus involvement of a supportive partner (social support) and sending reports to physicians (accountability) increases medication adherence in patients with hypertension and hyperlipidemia. The study will randomize 84 patients with hypertension, hyperlipidemia, and a history of poor medication adherence seen in a single Penn Medicine clinic to an 18-week gamification intervention or to attention control text messages alone.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension and Hyperlipidemia
• Intervention / Treatment: Behavioral: HTN and Medication Adherence

Detailed Description

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality in the United States. Hypertension and hyperlipidemia have been recognized as risk factors for ASCVD for more than 60 years, with several low-cost medications approved for treatment offering up to 88% reduction of cardiovascular events with perfect adherence. Poor medication adherence is an important contributor to poor risk factor control, and affects Black patients and those with low socioeconomic status to a greater extent than other populations. Interventions specifically targeting improved medication adherence in Black communities and those with low socioeconomic status may therefore improve cardiovascular health in these vulnerable groups. Previous trials have used multiple different methods to increase medical adherence, but few of these methods have been implemented due to their high cost and/or personnel-heavy approaches. Leveraging insights from behavioral economics may facilitate a lower touch, less expensive, and ultimately more scalable approach to increase medication adherence. Therefore, the investigators will perform a randomized controlled trial of a gamification intervention that leverages insights from behavioral economics-based versus attention control to determine the effect of the gamification intervention on medication adherence. Participants will include patients with poorly-controlled hypertension, hyperlipidemia, and a history of nonadherence to medications from a single clinic that serves patients from West and Southwest Philadelphia, a community with a high proportion of Black individuals. Patients in both arms will be provided with a blood pressure cuff and enrolled in an automated bidirectional text messaging platform that will send daily texts asking about medication adherence and twice weekly texts asking if participants have measured their blood pressure that day. The intervention arm will include a precommitment pledge, weekly progression (or regression) through levels with loss-framing of points, support from a family member or friend, and accountability from a primary care physician. After 18 weeks, changes in patient-reported medication adherence (primary outcome) will be compared between study arms along with patient-reported blood pressure and medication possession ratio (MPR).

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Prescribed 1 or 2 blood pressure medications and a statin medication for > 1 year
• Has supply of medications at the time of enrollment
• Medication possession ratio 40-80% for at least one of those medications for the past 6 months
• Systolic blood pressure > 140 mm Hg at most recent check
• Owns a smartphone or tablet operating the iOS or Android operating system

Exclusion Criteria:

• Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension of English)
• Systolic blood pressure > 180 mm Hg at their last bp check
• Anticipated life expectancy less than 6 months
• Any other reason why it is not feasible to complete the entire study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Via the Way to Health platform, all participants will receive daily text messages asking about medication adherence for that day and twice weekly text messages asking if participants have measured blood pressure on that day.
Experimental: Intervention; Via the Way to Health platform, all patients will receive daily text messages asking about medication adherence for that day and twice weekly text messages asking if participants have measured blood pressure on that day. Participants are entered into a game. Each week they receive 90 points. If they took their medications or checked their blood pressure the prior day, they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 70 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner. At the start of the intervention, the study team holds a 3-way phone call with the participant and support partner to discuss ways they can help the participant meet their goal. The support partner gets a weekly email with the participant's progress. Primary care physicians will receive a monthly email noting patients' self-reported adherence and blood pressure.	Behavioral: HTN and Medication Adherence; Via the Way to Health platform, all patients will receive daily text messages asking about medication adherence for that day and twice weekly text messages asking if participants have measured blood pressure on that day. Participants are entered into a game. Each week they receive 90 points. If they took their medications or checked their blood pressure the prior day, they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 70 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner. At the start of the intervention, the study team holds a 3-way phone call with the participant and support partner to discuss ways they can help the participant meet their goal. The support partner gets a weekly email with the participant's progress. Primary care physicians will receive a monthly email noting patients' self-reported adherence and blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-reported adherence	Patient reported adherence will be defined as days taking all prescribed antihypertensive medications and statins divided by total days in the study over the entire study duration; this will be compared between study arms	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure over study duration	Patients will measure their systolic and diastolic blood pressure twice weekly using a blood pressure cuff provided by the study and report the values via text message. We will compare change in systolic and diastolic blood pressure from study start to the end of the study between intervention and control arms	18 weeks
Patient-reported adherence in weeks 14-18	Patient reported adherence will be defined as days taking all prescribed antihypertensive medications and statins divided by total days in the study during study weeks 14-18; this will be compared between study arms.	5 weeks (during study weeks 14-18)
Medication possession ratio over study duration	Medication possession ratio will be calculated as the number of days that a patient has a supply of medication divided by the total number of days in the study; this will be compared between arms	18 weeks
Medication possession ratio in weeks 14-18	Medication possession ratio will be calculated as the number of days that a patient has a supply of medication divided by the total number of days in the study from weeks 14-18; this will be compared between arms	5 weeks (during study weeks 14-18)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in low density lipoprotein cholesterol	At the end of the study, participants will have their low density lipoprotein cholesterol checked. We will compare the change from baseline to follow-up LDL between arms.	18 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Alexander Fanaroff, MD, MHS, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Hyperlipidemias
• Other Study ID Numbers: 850287

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No