1) Is e-COGRAT usable within the ABI population?2) What are the patients* experiences with e-COGRAT?3) What are the therapists* experiences with e-COGRAT?4) What changes in the e-COGRAT are necessary?5) Does this pilot with e-COGRAT show a decline…
ID
Source
Brief title
Condition
- Structural brain disorders
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients:
- Questionnaire concerning user experience of the e-COGRAT
- Fatigue: Checklist Individuele Spankracht (CIS-20R, J. H. Vercoulen et al.,
1994; J. H. H. M. Vercoulen et al., 1999) & Dutch Multifactor Fatigue Scale
(DMFS, Visser-Keizer, A.C. et al., 2015).
- During the treatment period patients will be asked weekly about physical and
mental change (scale 1-10) and physical and mental fatigue (scale 1-10).
- Quality of life: RAND36 (van der Zee & Sanderman, 2012).
Therapists:
- Demographics (age, profession, number of working years)
- Semi-structured interview about using the internet and applications and
experiences with eHealth.
- Questionnaire concerning user experience of the e-COGRAT
- Semi-structured interview concerning user experiences
Secondary outcome
Patients:
- Anxiety and depression: Hospital Anxiety and Depression Scale (HADS) (Zigmond
& Snaith, 1983).
- Psychosocial distress: Brief Symptom Inventory (BSI) (Derogatisa &
Melisaratosa, 1983).
- Executive problems: Dysexecutive Questionnaire (DEX) (Alderman, Evans,
Burgess, & Wilson, 1993).
- Happiness-question (7-point Likert scale).
- Information about work sick leave and use of health care: questionnaire
User-P.
Background summary
Fatigue is a common and often very restricting complaint following acquired
brain injury (ABI). To better cope with this fatigue, an effective protocol has
been developed: the COGRAT (Cognitive and Graded Activity training Zedlitz
AMEE, Fasotti L & Geurts ACH, Clinical Rehabilitation, 2011).
The current study is a pilot / feasibility study, aiming to develop a blended
care / e-health variant, the e-COGRAT.
Using focus groups (both patients and therapists) the COGRAT will be converted
into a (partially) digital module, the e-COGRAT.
Subsequently this module will be tested - with small groups of patients - for
feasibility (pilot).
In the future (beyond the scope of the current study) effectiveness and
cost-effectiveness will be further investigated.
Study objective
1) Is e-COGRAT usable within the ABI population?
2) What are the patients* experiences with e-COGRAT?
3) What are the therapists* experiences with e-COGRAT?
4) What changes in the e-COGRAT are necessary?
5) Does this pilot with e-COGRAT show a decline in (subjective) fatigue
compared to former research concerning COGRAT in rehabilitation setting?
6) Is the e-COGRAT more efficient than the COGRAT in terms of time investment
of therapists and travel time of patients?
7) Is the for adolscents developed treatment usable for these adolescents?
Study design
A. Using focus groups, COGRAT will be converted to e-COGRAT
B. This first version of e-COGRAT will be evaluated on feasibility with a small
group of patients and therapists.
Intervention
Focus Groups:
Per group, 4 meetings will be planned on well accessible locations
Treatment Groups:
Originally, COGRAT consisted of 12 cognitive therapy group sessions and 24
Graded Activity Training sessions in a 12-week period. In e-COGRAT this will be
reduced (exact numbers are partially dependent of the results obtained from the
focus groups) to 4 life-sessions of cognitive therapy and 12 sessions of Graded
Activity Training. All other sessions will be presented digitally.
Study burden and risks
The burden for the patients is equal to or less than when participating in
regular treatment for fatigue.
The extra burden consists of participating in the focus groups (if applicable)
and filling out questionnaires and evaluation forms.
The risk is estimated to be nil.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
- age 15-24 (group 1)
- age > 24 (group 2)
- acquired brain injury (ABI) at least 3 months prior to inclusion
- suffering from (severe) chronic fatigue
- being able to walk at least 30 feet independently
- have access to a computer with internet connection and know the basics to use it.
Exclusion criteria
- severe comorbid heart and/or long-disease
- comorbid psychiatric disorder (depression or personality disorder)
- IQ below 80
- severe cognitive disorders (neglect, aphasia, memory-disorders or disinhibition).
Design
Recruitment
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 | NL54404.058.16 |