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Gamification and Medication Adherence (GAME Adherence)

Primary Purpose

Hypertension and Hyperlipidemia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HTN and Medication Adherence
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension and Hyperlipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 on two most recent checks
  • 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 on either of their last two checks
  • Anticipated life expectancy less than 6 months
  • Any other reason why it is not feasible to complete the entire study

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
March 21, 2022
Last Updated
October 11, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05326386
Brief Title
Gamification and Medication Adherence (GAME Adherence)
Official Title
Gamification and Social Incentives to Augment Medication Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension and Hyperlipidemia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
HTN and Medication Adherence
Intervention Description
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.
Primary Outcome Measure Information:
Title
patient-reported adherence
Description
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
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Change in blood pressure over study duration
Description
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
Time Frame
18 weeks
Title
Patient-reported adherence in weeks 14-18
Description
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.
Time Frame
5 weeks (during study weeks 14-18)
Title
Medication possession ratio over study duration
Description
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
Time Frame
18 weeks
Title
Medication possession ratio in weeks 14-18
Description
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
Time Frame
5 weeks (during study weeks 14-18)
Other Pre-specified Outcome Measures:
Title
Change in low density lipoprotein cholesterol
Description
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.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Fanaroff, MD, MHS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Gamification and Medication Adherence (GAME Adherence)

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