The main objective of the current proof-of-concept study is to explore the feasibility, acceptance and potential (clinical) added value of Sense-IT in a sample of psychiatric patients with ASD/ID/BPD and their psychiatric nurses.
ID
Source
Brief title
Condition
- Personality disorders and disturbances in behaviour
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters include the feasibility and acceptance of Sense-IT as
experienced by psychiatric patients with ASD/ID and/or BPD and psychiatric
nurses.
Secondary outcome
Secondary and tertiary parameters include:
- The potential (clinical) added value of Sense-IT in a sample of forensic
psychiatric patients with ASD/ID/BPD.
- The opinions of the participants (patients as well as staff) on the use of
Sense-IT and technology in general for improving clinical treatment.
Background summary
Disorders such as autism spectrum disorder (ASD), intellectual disability (ID)
and/or borderline personality disorder (BPD) are prevalent disorders in
psychiatric samples. Patients with ASD/ID and/or BPD are impaired in
recognizing increases in their physiological emotional reactivity, and are
limited in their ability to cope with the emotional responses to stress that
can result in challenging behaviours. The absence of treatments for improving
and regulating emotional responses in ASD/ID and/or BPD is a major unmet
clinical need. The use of wearable technology shows promise for improving
recognition of physiological emotional reactivity and, thus, potentially
reducing challenging behaviour. Therefore, the current study will explore the
feasibility, acceptance and potential (clinical) added value of Sense-IT, a
smartwatch application, in a sample of psychiatric patients with ASD/ID and/or
BPD and their psychiatric nurses.
Study objective
The main objective of the current proof-of-concept study is to explore the
feasibility, acceptance and potential (clinical) added value of Sense-IT in a
sample of psychiatric patients with ASD/ID/BPD and their psychiatric nurses.
Study design
The current study is a proof-of-concept study in which Sense-IT is examined
during inpatient psychiatric care at two sites of GGNet: FPA De Boog and
Scelta. Sense-IT will be worn by participants during their therapeutic program
and daily activities for the duration of two weeks.
Intervention
Sense-IT consists of one application for a smartwatch and a smartphone. The
part on the smartphone serves as a diary. The part on the smartwatch displays
heart rate as measured by the own sensors of the smartwatch on a scale of 1 to
5 dots. At first use, an individual baseline heart rate during rest is
determined. If subsequently a significant change (e.g. > 5 beats per minute) in
heart rate is registered, the user is informed by a vibrating signal and the
addition of 1 dot. The smartwatch application serves as a monitor to become
aware of the change in heart rate.
Study burden and risks
The risk for adverse events due to participation in this study is negligible,
especially since Sense-IT is examined as a part of the inpatient treatment
program and all patients are constantly monitored by forensic psychiatric
nurses. Also, participation in this study is completely voluntarily, and
participants can abort their participation at any time without any
clarifications.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Patients with ASD and/or ID
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1) is admitted to inpatient care at FPA De Boog, GGNet, Warnsveld
2) is diagnosed with ASD and/or ID according to DSM-5 criteria (APA,
2013)
3) is mentally competent and willing to participate in the study
Patients with BPD
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1) is admitted to inpatient care at Scelta, GGNet, Apeldoorn
2) is diagnosed with BPD according to DSM-5 criteria (APA, 2013)
3) is mentally competent and willing to participate in the study
Nurses
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1) is working at FPA De Boog, GGNet or at Scelta, GGNet
Exclusion criteria
Patients
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1) is unable to read, speak or write the Dutch language
2) is using beta-blockers, Nurses
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1) is unable to read, speak or write the Dutch language.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65285.044.18 |
| Other | NTR29261 |
| OMON | NL-OMON21447 |
| OMON | NL-OMON27963 |