Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-10 @ 10:49 PM
Study NCT ID:
NCT03080168
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The "AIM Study": Investigating Whether Actigraphy and Ideation Measures Can Promote Patient Safety
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker
Status:
COMPLETED
Status Verified Date:
2021-04
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:
AIM
Brief Summary:
This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions.
This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts.
In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.
This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts.
In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.
Detailed Description:
As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment was been placed on temporary administrative hold as of 3 17 2020. As the pandemic has continued, we have reviewed our data and decided to close the study to enrollment and proceed to our analyses of findings.
RESEARCH DESIGN: A prospective cohort study of Veterans will be conducted to determine if the previously-identified specific actigraphy-based measurements highly associated with suicidal ideation in non-Veterans will predict suicidal ideation, suicidal behavior, and/or rehospitalization in Veterans.
METHODS: An analysis of Veterans admitted to the Bedford, Massachusetts VAMC acute psychiatry unit will be conducted. The primary analysis will focus upon Veterans with current suicidal ideation or recent suicidal behavior (SI/SB) who do not have a primary psychotic disorder, Alzheimer's, or Parkinson's disease, and who are not undergoing alcohol detoxification. A separate analysis will be conducted of patients undergoing alcohol detoxification, half with SI/SB and half without SI/SB. Participants will wear a small, unobtrusive, wristwatch-like actigraph on their nondominant wrist, and complete self-rated and clinician-rated assessments of suicidal ideation, as well as self-rated assessments of the severity of other psychiatric symptoms. A Resiliency Index (RI) will be calculated using nonlinear dynamic analysis of the amplitude of movements over time frames from 6 minutes - 2 hours. These time frames are the periods for which a clear structure to the movement data is evident, with patients with suicidal ideation showing less variation in amplitude than patients without suicidal ideation. If medications given for alcohol detoxification are determined to not interfere with the RI, then a secondary analysis will examine the entire sample of Veterans. One Aim will focus upon determining whether the original Resiliency Index or alternative movement data indices, such as one based on the change in the movement data over the hospitalization, predicts the presence and severity of suicidal ideation among Veteran inpatients. This aim will also examine the sensitivity and specificity of the RI for detecting the presence of any suicidal ideation, and of substantial suicidal ideation. (In non-Veterans, the RI showed a sensitivity of 72% and a specificity of 100% for detecting any suicidal ideation, and 86% and 88%, respectively, for detecting substantial ideation). In addition, the investigators may determine whether the RI predicts subsequent suicidal behavior or rehospitalization over different time periods within the original 12 month followup period, alone or combined with data about symptom severity, past history, and the present hospitalization.
RESEARCH DESIGN: A prospective cohort study of Veterans will be conducted to determine if the previously-identified specific actigraphy-based measurements highly associated with suicidal ideation in non-Veterans will predict suicidal ideation, suicidal behavior, and/or rehospitalization in Veterans.
METHODS: An analysis of Veterans admitted to the Bedford, Massachusetts VAMC acute psychiatry unit will be conducted. The primary analysis will focus upon Veterans with current suicidal ideation or recent suicidal behavior (SI/SB) who do not have a primary psychotic disorder, Alzheimer's, or Parkinson's disease, and who are not undergoing alcohol detoxification. A separate analysis will be conducted of patients undergoing alcohol detoxification, half with SI/SB and half without SI/SB. Participants will wear a small, unobtrusive, wristwatch-like actigraph on their nondominant wrist, and complete self-rated and clinician-rated assessments of suicidal ideation, as well as self-rated assessments of the severity of other psychiatric symptoms. A Resiliency Index (RI) will be calculated using nonlinear dynamic analysis of the amplitude of movements over time frames from 6 minutes - 2 hours. These time frames are the periods for which a clear structure to the movement data is evident, with patients with suicidal ideation showing less variation in amplitude than patients without suicidal ideation. If medications given for alcohol detoxification are determined to not interfere with the RI, then a secondary analysis will examine the entire sample of Veterans. One Aim will focus upon determining whether the original Resiliency Index or alternative movement data indices, such as one based on the change in the movement data over the hospitalization, predicts the presence and severity of suicidal ideation among Veteran inpatients. This aim will also examine the sensitivity and specificity of the RI for detecting the presence of any suicidal ideation, and of substantial suicidal ideation. (In non-Veterans, the RI showed a sensitivity of 72% and a specificity of 100% for detecting any suicidal ideation, and 86% and 88%, respectively, for detecting substantial ideation). In addition, the investigators may determine whether the RI predicts subsequent suicidal behavior or rehospitalization over different time periods within the original 12 month followup period, alone or combined with data about symptom severity, past history, and the present hospitalization.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1I01CX001424-01 | NIH | None | https://reporter.nih.gov/quic… | View |