Gamification and Medication Adherence (GAME Adherence)

NCT05326386 | Active Not Recruiting

• 1 other identifier: 850287
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension and Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in blood pressure over study duration

  18 weeks

• Patient-reported adherence in weeks 14-18

  5 weeks (during study weeks 14-18)

• Medication possession ratio over study duration

  18 weeks

• Medication possession ratio in weeks 14-18

  5 weeks (during study weeks 14-18)

Other Outcomes (1)

• Change in low density lipoprotein cholesterol

  18 weeks

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

HTN and Medication Adherence BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Fanaroff AC, Clark K, Reid-Bey L, Rareshide C, Zhu J, Norton L, Volpp KG. A pilot randomized clinical trial of gamification to increase medication adherence. Am Heart J. 2026 Mar 7:107419. doi: 10.1016/j.ahj.2026.107419. Online ahead of print.

  PMID: 41802527 DERIVED

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexander Fanaroff, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 13, 2022
• Study Start: September 12, 2022
• Primary Completion: January 31, 2024
• Study Completion: May 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)