Clinical trial NCT05326386: Gamification and Medication Adherence (GAME Adherence)
Official title: Gamification and Social Incentives to Augment Medication Adherence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension and Hyperlipidemia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: patient-reported adherence
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in blood pressure over study duration
timeFrame: 18 weeks
measure: Patient-reported adherence in weeks 14-18
timeFrame: 5 weeks (during study weeks 14-18)
measure: Medication possession ratio over study duration
timeFrame: 18 weeks
measure: Medication possession ratio in weeks 14-18
timeFrame: 5 weeks (during study weeks 14-18)
Other outcomes:
measure: Change in low density lipoprotein cholesterol
timeFrame: 18 weeks
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Alexander Fanaroff, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: