Hypertension and HyperlipidemiaNCT05326386
Gamification and Medication Adherence (GAME Adherence)
A study testing HTN and Medication Adherence in people with Hypertension and Hyperlipidemia, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension and Hyperlipidemia
- What is being tested?
- HTN and Medication Adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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).
- Conditions
- Hypertension and Hyperlipidemia
- Being tested
- HTN and Medication Adherence
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTN and Medication AdherenceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HTN and Medication Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 5 weeks (during study weeks 14-18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start12 Sep 2022
- Primary completion31 Jan 2024
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension and HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Fanaroff, MD, MHS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326386
- Sponsor's protocol ID
- 850287
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Jul;297:107419. doi: 10.1016/j.ahj.2026.107419. Epub 2026 Mar 7.
PubMed 41802527
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamification and Social Incentives to Augment Medication Adherence
- ClinicalTrials.gov ID
- NCT05326386
- Acronym / sponsor ID
- 850287
- Conditions
- Hypertension and Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: HTN and Medication AdherenceVia 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTN and Medication AdherenceVia 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. | Behavioural | Intervention |
Primary outcome
patient-reported adherence
Time frame: 18 weeks
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
4 secondary outcomes
Change in blood pressure over study duration
Time frame: 18 weeks
Patient-reported adherence in weeks 14-18
Time frame: 5 weeks (during study weeks 14-18)
Medication possession ratio over study duration
Time frame: 18 weeks
Medication possession ratio in weeks 14-18
Time frame: 5 weeks (during study weeks 14-18)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 41802527Fanaroff 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 Jul;297:107419. doi: 10.1016/j.ahj.2026.107419. Epub 2026 Mar 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Fanaroff, MD, MHS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTN and Medication Adherence in people with Hypertension and Hyperlipidemia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported adherence (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.