Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03853213
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2019-02-22
Brief Title:
Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
Status:
COMPLETED
Status Verified Date:
2021-08
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:
INFORM
Brief Summary:
The primary goal of this project is to identify measure and influence fear of cardiac event recurrence a candidate mechanism of change in medication adherence in patients with suspected acute coronary syndrome ACS An intervention will be tested that has been used to reduce fear of cancer recurrence by changing emotion-related patterns of attention allocation and interpretation of neutral stimuli Secondarily the study will test whether a reduction in fear of cardiac event recurrence improves medication adherence
Detailed Description:
Acute coronary syndrome ACS myocardial infarction or unstable angina is a leading cause of morbidity and mortality in the US with 1 million cases per year Survivors are at high risk for recurrent cardiovascular disease CVD events particularly if they do not adhere to risk-reducing medications Unfortunately nonadherence among ACS patients is very common 50 and no effective scalable interventions exist Addressing medication nonadherence in ACS patients requires an experimental medicine approach to identify specific mechanisms of behavior change in populations for whom those mechanisms are most relevant and modifiable
Accumulating evidence suggests that the many patients who develop post-traumatic stress disorder PTSD symptoms following ACS view their medications as reminders of their cardiac event and their future CVD risk Ironically although it has rarely been studied outside of cancer survivors this fear of recurrence FoR may undermine medication adherence in ACS patients This project will use the Science of Behavior Change SOBC experimental medicine approach to investigate FoR as a putative mechanism of behavior change with respect to heart medication adherence among ACS patients with early PTSD symptoms at hospital discharge The study will test a cognitive-affective intervention that has been shown to reduce FoR in cancer survivors that is delivered electronically electronic tablet in the patients home The intervention has been adapted in this study for ACS to be tested using a double-blind randomized controlled design One hundred suspected ACS patients will be enrolled who reported at least mild to moderate threat perceptions at the time of their initial visit to the emergency department FoR and future time perspective will be assessed within six weeks of the initial visit to the emergency department and then participants will be trained on the tablet intervention Participants will complete the intervention over four weeks in eight half-hour sessions twice each week Medication adherence will be measured electronically using eCAP devices FoR and future time perspective will be reassessed 1 month after the baseline session and cognitive-affective change will be assessed electronically throughout the intervention period
In addition to investigating FoR as the primary mechanism of behavior change the study also investigates a secondary potential mechanism that is a distinct but related construct future time perspective Furthermore in addition to examining medication adherence as the primary health behavior of interest the study also examines a secondary health behavior that is reduced in fearful cardiac patients physical activity Collectively the three aims below address these two putative mechanisms FoR future time perspective and these two health behaviors medication adherence physical activity in the randomly assigned groups intervention control
Objectives
Aim 1 main purpose of the trial
The study will determine whether a tablet-based cognitive bias modification treatment CBMT intervention influences the two putative mechanisms of fear of recurrence FoR and future time perspective Of primary importance within this first aim it will test whether the intervention reduces cardiac-related FoR relative to control The trial is statistically powered to test the first aim as it relates to FoR Secondarily it will also test whether the intervention increases an expansive future time perspective relative to control
Aim 2 exploratory
The study will determine the extent to which the two potential mechanisms of behavior change-FoR and future time perspective-are each associated with health behaviors Of primary importance within this second aim it will test associations between these two potential mechanisms of behavior change and objectively measured and self-reported adherence to heart medications antiplatelets to reduce risk of blood clotting antihypertensive drugs to reduce blood pressure or statins to lower cholesterol Of secondary importance it will test whether these two potential mechanisms of behavior change are associated with self-reported physical activity
Aim 3 exploratory
The study will test whether the intervention improves the two health behaviors of interest Of primary importance within this third aim it will test whether the intervention relative to control is associated with higher heart medication adherence objectively measured or self-reported in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective Secondarily it will test whether the intervention relative to control is associated with greater increases in self-reported physical activity in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective
Accumulating evidence suggests that the many patients who develop post-traumatic stress disorder PTSD symptoms following ACS view their medications as reminders of their cardiac event and their future CVD risk Ironically although it has rarely been studied outside of cancer survivors this fear of recurrence FoR may undermine medication adherence in ACS patients This project will use the Science of Behavior Change SOBC experimental medicine approach to investigate FoR as a putative mechanism of behavior change with respect to heart medication adherence among ACS patients with early PTSD symptoms at hospital discharge The study will test a cognitive-affective intervention that has been shown to reduce FoR in cancer survivors that is delivered electronically electronic tablet in the patients home The intervention has been adapted in this study for ACS to be tested using a double-blind randomized controlled design One hundred suspected ACS patients will be enrolled who reported at least mild to moderate threat perceptions at the time of their initial visit to the emergency department FoR and future time perspective will be assessed within six weeks of the initial visit to the emergency department and then participants will be trained on the tablet intervention Participants will complete the intervention over four weeks in eight half-hour sessions twice each week Medication adherence will be measured electronically using eCAP devices FoR and future time perspective will be reassessed 1 month after the baseline session and cognitive-affective change will be assessed electronically throughout the intervention period
In addition to investigating FoR as the primary mechanism of behavior change the study also investigates a secondary potential mechanism that is a distinct but related construct future time perspective Furthermore in addition to examining medication adherence as the primary health behavior of interest the study also examines a secondary health behavior that is reduced in fearful cardiac patients physical activity Collectively the three aims below address these two putative mechanisms FoR future time perspective and these two health behaviors medication adherence physical activity in the randomly assigned groups intervention control
Objectives
Aim 1 main purpose of the trial
The study will determine whether a tablet-based cognitive bias modification treatment CBMT intervention influences the two putative mechanisms of fear of recurrence FoR and future time perspective Of primary importance within this first aim it will test whether the intervention reduces cardiac-related FoR relative to control The trial is statistically powered to test the first aim as it relates to FoR Secondarily it will also test whether the intervention increases an expansive future time perspective relative to control
Aim 2 exploratory
The study will determine the extent to which the two potential mechanisms of behavior change-FoR and future time perspective-are each associated with health behaviors Of primary importance within this second aim it will test associations between these two potential mechanisms of behavior change and objectively measured and self-reported adherence to heart medications antiplatelets to reduce risk of blood clotting antihypertensive drugs to reduce blood pressure or statins to lower cholesterol Of secondary importance it will test whether these two potential mechanisms of behavior change are associated with self-reported physical activity
Aim 3 exploratory
The study will test whether the intervention improves the two health behaviors of interest Of primary importance within this third aim it will test whether the intervention relative to control is associated with higher heart medication adherence objectively measured or self-reported in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective Secondarily it will test whether the intervention relative to control is associated with greater increases in self-reported physical activity in the two months after the baseline visit and whether any such beneficial effects are mediated by reductions in the putative mechanisms of FoR or future time perspective
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 |
|---|---|---|---|
| R21HL145970-01 | NIH | None | httpsreporternihgovquickSearchR21HL145970-01 |