Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03292393
Status:
WITHDRAWN
Last Update Posted:
2018-11-07
First Post:
2017-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Norms and Antihypertensive Medication Adherence
Sponsor:
Florida International University
Organization:
Study Overview
Official Title:
Social Norms and Antihypertensive Medication Adherence
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough sample list at participating healthcare facility.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: