Clinical trial NCT03292393: Social Norms and Antihypertensive Medication Adherence
Official title: Social Norms and Antihypertensive Medication Adherence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Medication Adherence
Keywords: Hypertension
Medication
Adherence
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study objective is to build group social norms to improve individual adhere to antihypertensive medications. Financial incentives are provided to individuals contingent upon group behavioral changes. Groups of patients will be formed, and incentivized to interact on a daily basis through social media and participate in a monthly-facilitated meeting at a local clinic. By forming groups, making individual outcomes transparent, and setting financial incentives contingent to group targets, individual decisions are framed within emerging social norms.

Detailed description: We propose a pilot study that will inform, provide inputs and reduce the risk of a larger implementation. The project consists of three phases: The pre-intervention phase, the intervention phase, and the post-intervention phase. The pre-intervention phase includes the recruitment and selection of participants, and a one-month collection of baseline blood pressure and medication adherence levels of participants before they are assigned to a treatment arm. All participants will receive compensation for participation.

In the intervention phase participants will be randomly assigned to one of the three treatment arms and they will receive the financial incentive that corresponds to their treatment arm. Data will be collected for four months and all participants will continue receiving a compensation for participation.

During the post-intervention phase, contingency payments will be cut off, and only compensation for participation will remain. Data will be collected for three months in the post-intervention phase.

The primary outcome of the study is medication adherence which will be measured using two different methods. The first method is through the use of eCaps (electronic caps). The second method is through a monthly randomized phone call during which the participant will be asked to perform a pill count of their medication.

The secondary outcome of the study is blood pressure which will be measured using two different instruments . The first instrument will be the ambulatory blood pressure monitor (ABPM). The second instrument will be a home blood pressure monitor (HBPM) which researchers will provide to the participant to use for the duration of the study.

All participants of the study will receive an unconditional payment each time they provide a blood pressure reading from the ABPM. Financial incentives (contingent to change in behavior -conditional to change in adherence). In addition to the unconditional payment, participants in the ICM and GCM treatment arms will receive a financial incentive that is conditional to medication adherence.

Eligibility criteria: Inclusion Criteria:

* Person has been diagnosed with essential hypertension for at least a year (no new or recently diagnosed hypertensive patients)
* Person is currently taking no more than 2 medications
* Person has taken the same anti-hypertensive medication for at least a year (no recent changes in medication)
* Person reports not being adherent to anti-hypertensive medication
* Speaks English or Spanish, currently insured
* Has access to the Internet
* Willing to participate in social media, able to go to West Kendall Baptist Hospital
* Available for the next 8 months

Exclusion Criteria:

* Persons with Secondary hypertension
* Persons with coronary heart disease, cerebrovascular disorders or atrial fibrillation,
* Persons with rubber allergy, or bedridden, wheelchair bound.
* Persons who have had a stroke or myocardial infarction within the previous 6 months, are pregnant, or have any serious chronic disease will also be excluded from the study.

Primary outcomes:
measure: Self Assessed Medication Adherence
timeFrame: Monthly over 8 months
Secondary outcomes:
measure: Self Assessed Diastolic Blood pressure (mm Hg)
timeFrame: Monthly over 8 months
measure: Automatic measure of Medication Adherence
timeFrame: Daily over 8 months
measure: Self Assessed Systolic Blood pressure (mm Hg)
timeFrame: Monthly over 8 months
measure: Automatic measure of Diastolic Blood pressure (mm Hg)
timeFrame: Three times over 8 months
measure: Automatic measure of Systolic Blood pressure (mm Hg)
timeFrame: Three times over 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Florida International University
name: Alejandro Arrieta, PhD
role: PRINCIPAL_INVESTIGATOR
References: