The primary study objective is to examine functionality and usability of a newly developed eHealth and serious gaming intervention, to ensure that the intervention is user-friendly and fits the needs of potential users. Based on these functionality…
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
- Cornification and dystrophic skin disorders
Synonym
Health condition
Het onderzoek wordt uitgevoerd onder patiënten met chronische aandoeningen die gepaard gaan met jeuk (zoals psoriasis of eczeem) en/of pijn (zoals reumatoïde artritis of fibromyalgie), en onder gezonde mensen.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of this pilot study is the usability of the eHealth
and serious gaming intervention, assessed by questionnaires and semi-structured
interviews using a think-aloud protocol during a single usability session at
Leiden University (duration: 2 hours).
Secondary outcome
Not applicable.
Background summary
Studies show that expectations about health and disease can directly affect
health and treatment outcomes, for example by inducing anti-inflammatory
effects. In this project, knowledge on the effects of implicit and explicit
expectancy mechanisms such as conditioning and verbal suggestions is applied in
a psychological eHealth and serious gaming intervention aimed to optimize
health outcomes. In the current project, a prototype of this intervention will
be further refined and improved.
Study objective
The primary study objective is to examine functionality and usability of a
newly developed eHealth and serious gaming intervention, to ensure that the
intervention is user-friendly and fits the needs of potential users. Based on
these functionality and usability tests, the intervention can be further
improved prior to the proposed pilot feasibility study (fase 3
[TRAIN-HEAL-TH-3]: Protocol will be submitted to the CME shortly).
Study design
The proposed observational study consists of a user-based usability assessment
in which targeted end-users will be asked to use the intervention based on a
concurrent think-aloud protocol during a single meeting at Leiden University
and to evaluate its user-friendliness. Both the healthy volunteers and the
patients with a chronic pain or itch condition will be shown a psychological
(non-pharmacological) eHealth and serious gaming intervention directing at
optimizing health outcomes. The intervention is based on cognitive behavioural
treatment in combination with automatic and conscious expectancy learning
principles (see p. 15 for intervention description). The intervention is
designed to be used by participants for 6-12 weeks. However, in this study
participants will be shown the intervention once to examine functionality and
usability.
Study burden and risks
There are no risks involved with participation in this study, only a time
investment of 2 hours for the usability session. There are no direct benefits
for subjects participating in this study. The major contribution of this study
is that an innovative non-pharmacological treatment aimed at optimizing health
outcomes without pharmacological drugs could be useful as an addition, or
ultimately replacement of, current drug treatments. This may lead to new
therapeutic possibilities for patients with chronic somatic conditions
requiring long-term pharmacological treatment.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
For healthy volunteers:
- age * 18 years
- sufficient understanding of the Dutch language;For patients with a chronic pain or chronic itch condition:
- age * 18 years
- sufficient understanding of the Dutch language
- confirmed diagnosis of chronic pain condition or chronic itch condition
Exclusion criteria
For healthy volunteers:
- confirmed diagnosis of chronic pain condition or chronic itch condition
- severe physical or mental conditions (e.g., malignancy, psychosis, DSM-V diagnosis [American Psychiatric Association, 2013]) that interfere with the study protocol
- pregnancy;For patients with a chronic pain or chronic itch condition:
- severe physical or mental conditions (e.g., malignancy, psychosis, DSM-V diagnosis [American Psychiatric Association, 2013]) that interfere with the study protocol
- pregnancy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58186.058.16 |