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Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change (INFORM)

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ClinicalTrials.gov Identifier: NCT03853213
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Birk, Columbia University

Tracking Information
First Submitted Date  ICMJE February 22, 2019
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Change in Total Score for Concerns about Recurrence Scale [Adapted for Acute Coronary Syndrome] [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
This 19-item self-report scale measures fear of recurrence of ACS events. It uses a 5-point Likert scale (0 to 4). It has three subscales: health worries (items 1-11; subscale range: 0-44), role worries (items 12-17: subscale range: 0-24), and death worries (items 18-19: subscale range: 0-8). The total score is computed as the sum of all items in the scale (total score range: 0 to 76). Higher total scores indicate greater fear of recurrence. The study will test whether there is a larger Time-1-to-Time-2 reduction in Concerns about Recurrence total scores for the intervention group relative to the control group. This is the sole primary outcome because the trial design was statistically powered to reduce FoR.
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • Change in Total Score for Concerns about Recurrence Scale [Adapted for Acute Coronary Syndrome] [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This self-report scale measures fear of recurrence of ACS events. It has three subscales: health worries, role worries, and death worries. The total score is computed as the sum of all items in the scale. The study will test whether there is a larger Time-1-to-Time-2 reduction in Concerns about Recurrence total scores for the intervention group relative to the control group.
  • Change in total score for Future Time Perspective Scale [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This self-reported scale measures participants' perceptions of their own futures as either limited (lower scores) or expansive (higher scores). The total score is the sum of all 10 items (after three of the items have been reverse-coded). The study will test whether there is a larger Time-1-to-Time-2 increase in Future Time Perspective total scores for the intervention group relative to the control group.
  • Proportion of adherent days to medication (aspirin, beta-blocker, or statin) [ Time Frame: Up to 2 months (starting after Pre-Training/Time 1 and extending for approximately 4 weeks after Post-Training/Time 2) ]
    Participants' post-hospitalization medication adherence is measured objectively through electronically recorded pill bottle openings using the eCAP device (Information Mediary Corp., Ottawa, Canada). The measure is operationalized as the proportion of adherent days. The study will test whether there is a higher proportion of adherent days across the entire study monitoring period for the intervention group relative to the control group.
Change History Complete list of historical versions of study NCT03853213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Total for self-reported extent of nonadherence to medication from the Extent of and Reasons for Nonadherence Scale [Adapted] [ Time Frame: Post-Training/Time 2 (approximately 4 weeks after Time 1) ]
    The self-reported scale called the Extent of and Reasons for Nonadherence Scale [Adapted] measures how often participants do not take their prescribed medication and the reasons that they were nonadherent (e.g., forgot, out of routine, feeling down or upset). The measure of extent of nonadherence is the total of 3 items in the extent portion of the scale such that higher scores represent greater nonadherence (total score range: 3-15). The study will test whether there are lower self-reported extent of nonadherence scores for the intervention group relative to the control group at time 2. (Because not all participants are expected at time 1 to have been already taking the particular heart medication assessed in the study, the self-reported questions about medication adherence are only administered at time 2.)
  • Change in total score for the International Physical Activity Questionnaire in MET minutes/week [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This 7-item self-report scale measures the extent to which participants engaged in physical activity at a variety of intensity levels during the last week. Higher scores represent greater total metabolic equivalent of task (MET) minutes of physical activity per week based on the following estimates: 3.3 MET units for walking, 4.4 MET units for moderate activity, 8 MET units for vigorous activity. The study will test whether there is a larger Time-1-to-Time-2 increase in total scores on the International Physical Activity Questionnaire (units: MET minutes/week) for the intervention group relative to the control group.
  • Change in cue presence score for the Context Sensitivity Index [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This self-report scale measures participants' ability to identify information about stressful situations that may be helpful for successfully and flexibly regulating unpleasant feelings of distress. In particular, the cue presence score reflects the sensitivity to the presence of meaningful contextual cues. This cue presence score is calculated as the sum of 10 relevant items from the scale. Greater cue presence scores indicate greater context sensitivity (cue presence score range: 10-77). The study will test whether there is a larger Time-1-to-Time-2 increase in cue presence scores on the Context Sensitivity Index for the intervention group relative to the control group.
  • Change in total score for Future Time Perspective Scale [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This 10-item self-reported scale measures participants' perceptions of their own futures as either limited (lower scores) or expansive (higher scores). The total score is the sum of all 10 items after three of the items (8-10) have been reverse-coded (total score range: 10-77). The study will test whether there is a larger Time-1-to-Time-2 increase in Future Time Perspective total scores for the intervention group relative to the control group.
  • Proportion of adherent days to medication (aspirin, beta-blocker, or statin) [ Time Frame: Up to 2 months (starting after Pre-Training/Time 1 and extending for approximately 4 weeks after Post-Training/Time 2) ]
    Participants' post-hospitalization medication adherence is measured objectively through electronically recorded pill bottle openings using the eCAP device (Information Mediary Corp., Ottawa, Canada). The measure is operationalized as the proportion of adherent days. The study will test whether there is a higher proportion of adherent days across the entire study monitoring period for the intervention group relative to the control group.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • Change in total for self-reported extent of nonadherence to medication from the Extent of and Reasons for Nonadherence Scale [Adapted] [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    The self-reported scale called the Extent of and Reasons for Nonadherence Scale [Adapted] measures how often participants do not take their prescribed medication and the reasons that they were nonadherent (e.g., forgot, out of routine, feeling down or upset). The measure of extent of nonadherence is the total of all 5 items in the extent portion of the scale such that higher scores represent greater nonadherence. The study will test whether there is a larger Time-1-to-Time-2 reduction in self-reported extent of nonadherence scores for the intervention group relative to the control group.
  • Change in total score for the International Physical Activity Questionnaire in MET minutes/week [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    The self-report scale measures the extent to which participants engaged in physical activity at a variety of intensity levels during the last week. Higher scores represent greater total metabolic equivalent of task (MET) minutes of physical activity per week based on the following estimates: 3.3 MET units for walking, 4.4 MET units for moderate activity, 8 MET units for vigorous activity. The study will test whether there is a larger Time-1-to-Time-2 increase in total scores on the International Physical Activity Questionnaire (units: MET minutes/week) for the intervention group relative to the control group.
  • Change in cue presence score for the Context Sensitivity Index [ Time Frame: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart) ]
    This self-report scale measures participants' ability to identify information about stressful situations that may be helpful for successfully and flexibly regulating unpleasant feelings of distress. In particular, the cue presence score reflects the sensitivity to the presence of meaningful contextual cues. This cue presence score is calculated as the sum of 10 relevant items from the scale such that greater scores indicate greater context sensitivity. The study will test whether there is a larger Time-1-to-Time-2 increase in cue presence scores on the Context Sensitivity Index for the intervention group relative to the control group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change
Official Title  ICMJE Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
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 U.S., 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 patient's 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 CBMT intervention influences the two putative mechanisms of 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Acute Coronary Syndrome
  • Fear
  • Medication Adherence
Intervention  ICMJE
  • Behavioral: Cognitive Bias Modification Training
    In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., "dying") or benign (e.g., "sleep") interpretation of a sentence (e.g., "You have been waking up tired recently"). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback ("Correct") is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback ("Incorrect") is given.
    Other Name: Cognitive-Affective Fear of Recurrence Intervention
  • Behavioral: Attention Control Training
    In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations.
Study Arms  ICMJE
  • Experimental: Cognitive Bias Modification Training
    Participants in this intervention group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is Cognitive Bias Modification Training for Attention. It is designed to reinforce attention away from ACS threat-related stimuli (e.g., "death," "chest pain") and toward neutral stimuli (e.g., "curve," barn doors"). The second task is Cognitive Bias Modification Training for Interpretation. It is designed to train participants to appraise ambiguous information that is potentially related to ACS threat as benign.
    Intervention: Behavioral: Cognitive Bias Modification Training
  • Sham Comparator: Attention Control Training
    Participants in this placebo control group complete two tasks, each repeated 8 times over the course of 4 weeks (twice per week). The first task is the placebo version of Cognitive Bias Modification Training for Attention. It is designed NOT to train attention toward or away from threatening or neutral information. The second task is the placebo version of Cognitive Bias Modification Training for Interpretation. It is designed NOT to train the interpretation of information as either threatening or benign.
    Intervention: Behavioral: Attention Control Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 years or older;
  2. Fluent in English or Spanish;
  3. A diagnosis of NSTEMI or UA according to American College of Cardiology criteria;
  4. Currently enrolled in the protocol titled "Testing biopsychosocial mechanisms of the posthospital syndrome [PHS] model of early rehospitalization in cardiac patients" (IRB-AAAR7350 at CUIMC)
  5. Previously indicated "YES" to the following question in the consent form for the separate protocol (IRB-AAAR7350) in which they are enrolled and willing to be contacted about other future research projects.
  6. Elevated Threat Perception score in emergency department flagged by automatic scoring (i.e., ≥ 10, the median for 1,000 ACS patients in a separate sample)
  7. Currently on a daily aspirin regimen prescribed by a doctor OR currently on a daily beta-blocker or statin regimen prescribed by a doctor
  8. Some comfort using technology such as electronic tablets or smartphones

Exclusion Criteria:

  1. Deemed unable to comply with the protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia and patients with current alcohol or substance abuse;
  2. Deemed to need immediate psychiatric intervention (that is, has to be hospitalized or have some other psychiatric intervention within 72 hours);
  3. Unavailable for follow-up. This includes patients with a terminal noncardiovascular illness (life expectancy less than 1 year by physician report) and those who indicate they are about to leave the United States;
  4. Underwent a surgical procedure within the past 24 hours and/or is scheduled for a surgical procedure within the next 24 hours.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeffrey L Birk, PhD 212-342-5503 jlb2287@cumc.columbia.edu
Contact: Ian M Kronish, MD, MPH 212-342-1335 ik2293@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03853213
Other Study ID Numbers  ICMJE AAAR9458
R21HL145970-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey Birk, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jeffrey L Birk, PhD Columbia University Irving Medical Center
PRS Account Columbia University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP