The proposed investigation is an open label pilot study intended to establish the acceptability and feasibility of the Apollo in a population of Veterans. Exploratory data regarding biological signatures will also be collected.
Evaluation of Apollo requires a stepwise process in which initial aims are geared towards identifying biological signatures versus diagnosing, treating, mitigating or curing any conditions. Towards the end of identifying potential biological signatures, we hypothesize the following. 1) Participants who use the Apollo will have an attenuated physiological stress response as measured by improved heart rate variability (HRV) compared to baseline. 2) Participants who use Apollo will have attenuated perceived psychological stress measured by lower scores on psychological correlates of acute stress when compared to baseline
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
63
Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phone. Participants will use the Apollo for at least 30 minutes after waking up in the morning and at least 30 minutes before bed on the corresponding settings for those times of day. They will be given the Apollo Device TVS (10-200 Hz) to borrow which they will be instructed to wear for 6 +/- 2 weeks. They will be asked to continue to wear the device until all study data is collected.
Eastern Colorado Health Care System (ECHCS)
Aurora, Colorado, United States
Acceptability via Credibility Scale
The Credibility Scale is a three-item questionnaire that will be used to assess patients' sense of the Apollo Wearable Device credibility.
Time frame: 6 +/- 2 weeks
Acceptability via Expectancy Scale
The Credibility Scale is a two-item questionnaire that will be used to assess patients' expectations of the Apollo Wearable Device.
Time frame: 6 +/- 2 weeks
Acceptability via Client Satisfaction Questionnaire (CSQ)
Client Satisfaction Questionnaire (CSQ) is an eight-item questionnaire that will be used to assess patients' satisfaction with the intervention. The CSQ has good reliability and validity and has frequently been used to evaluate community mental health care.
Time frame: 6 +/- 2 weeks
Acceptability via Narrative Evaluation of Intervention Interview (NEII)
Narrative Evaluation of Intervention Interview (NEII) is a 16-item semi-structured interview that is designed to help participants evaluate and describe the process and outcome of an intervention.
Time frame: 6 +/- 2 weeks
Feasibility via Credibility Scale
The Credibility Scale is a three-item questionnaire that will be used to assess patients' sense of the Apollo Wearable Device credibility.
Time frame: 6 +/- 2 weeks
Feasibility via via Expectancy Scale
The Credibility Scale is a two-item questionnaire that will be used to assess patients' expectations of the Apollo Wearable Device.
Time frame: 6 +/- 2 weeks
Feasibility via Client Satisfaction Questionnaire (CSQ)
Client Satisfaction Questionnaire (CSQ) is an eight-item questionnaire that will be used to assess patients' satisfaction with the intervention. The CSQ has good reliability and validity and has frequently been used to evaluate community mental health care.
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Time frame: 6 +/- 2 weeks
Feasibility via Narrative Evaluation of Intervention Interview (NEII)
Feasibility will be aNarrative Evaluation of Intervention Interview (NEII) is a 16-item semi-structured interview that is designed to help participants evaluate and describe the process and outcome of an intervention. ssessed using the Credibility/Expectancy Scales, Client Satisfaction Questionnaire (CSQ), and the Narrative Evaluation of Intervention Interview (NEII).
Time frame: 6 +/- 2 weeks