Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05997914
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2023-07-25
Brief Title:
Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation Randomized Trial STORY-AF Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this study is to evaluate the effectiveness of a previously developed storytelling intervention on anticoagulation AC initiationpersistence in African American and Black patients with atrial fibrillationflutter The investigators hope to gain knowledge that may help treat atrial fibrillation or flutter and lower stroke and adverse cardiovascular event risks for African American and Black patients by increasing the use of blood thinning medications known as anticoagulants
Detailed Description:
This is a multi-site research study including sites of both the University of Massachusetts Chan Medical School UMass Memorial Healthcare System and the University of Michigan Medical Center Michigan
Baseline call During the baseline call the investigators will obtain verbal informed consent During the call the investigators will also collect demographic information and measure health literacy the latter using two validated single-item instruments the investigators have used before
Randomization The investigators will randomize patients to watch videos the investigators developed intervention versus informational videos controls More specifically the investigators will randomize patients separately by study site UMassMichigan using randomly permuted blocks of sizes 4 and 6 embedded into a prespecified table
Exit interview The exit interview will be conducted approximately 90 days from the date of enrollment with study participants Interview questions will relate to whether the patient has already started AC the likelihood of starting anticoagulation AC barriers to starting AC and burdensomeness and acceptability of the interview
Chart review The investigators will also perform chart review to capture information that will inform whether the investigators achieved balance in treatment allocation groups on important factors related to study outcomes Chart review will also provide covariate information which the investigators will use in outcome analysis Through HIPAA authorization the investigators will extract information related to age gender insurance status prior AC use CHA2DS2VASc stroke risk score comorbidities associated with bleeding and adherence to preventive health screening
Data Security Analyses will be performed using only limited datasets and only aggregate data will be reported All data will be used for research purposes only published data will not contain any individual identifiers and will be reported in the aggregate
The proposed study involves no more than minimal risk to participants
The potential benefits to subjects from study participation include increased knowledge of atrial fibrillation and AC and improved rates of adherence to AC guidelines This may in turn prevent strokes or limit bleeding that would otherwise have occurred without the benefit of this intervention
Baseline call During the baseline call the investigators will obtain verbal informed consent During the call the investigators will also collect demographic information and measure health literacy the latter using two validated single-item instruments the investigators have used before
Randomization The investigators will randomize patients to watch videos the investigators developed intervention versus informational videos controls More specifically the investigators will randomize patients separately by study site UMassMichigan using randomly permuted blocks of sizes 4 and 6 embedded into a prespecified table
Exit interview The exit interview will be conducted approximately 90 days from the date of enrollment with study participants Interview questions will relate to whether the patient has already started AC the likelihood of starting anticoagulation AC barriers to starting AC and burdensomeness and acceptability of the interview
Chart review The investigators will also perform chart review to capture information that will inform whether the investigators achieved balance in treatment allocation groups on important factors related to study outcomes Chart review will also provide covariate information which the investigators will use in outcome analysis Through HIPAA authorization the investigators will extract information related to age gender insurance status prior AC use CHA2DS2VASc stroke risk score comorbidities associated with bleeding and adherence to preventive health screening
Data Security Analyses will be performed using only limited datasets and only aggregate data will be reported All data will be used for research purposes only published data will not contain any individual identifiers and will be reported in the aggregate
The proposed study involves no more than minimal risk to participants
The potential benefits to subjects from study participation include increased knowledge of atrial fibrillation and AC and improved rates of adherence to AC guidelines This may in turn prevent strokes or limit bleeding that would otherwise have occurred without the benefit of this intervention
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21MD017646 | NIH | None | httpsreporternihgovquickSearchR21MD017646 |