The objective of the study is to develop and test a blended vision-specific E-health-based cognitive behavioral & self-management intervention (*E-nergEYEze*). Our specific goals are: (1) to further develop E-nergEYEze for visually impaired…
ID
Source
Brief title
Condition
- Other condition
- Vision disorders
Synonym
Health condition
Vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The intervention and control group will both answer questionnaires by telephone
to obtain research data. These interviews are conducted by blinded research
assistants at baseline (T0), 6 months (T2) and 12 months (T4).
The primary outcome measure is: severity of fatigue (Checklist Individual
Strengths-Fatigue Scale).
Secondary outcome
Usability study:
Use will be made of thinking aloud, semi-structured interviews, observation and
video recordings to assess usability.
RCT:
The secondary outcome measured are: impact of fatigue (measured with the
Modified Fatigue Impact Scale; Adaptation to vision loss-9), depression
(measured with thePatient Health Questionnaire-9 (depression), Anxiety
(measured with the Hospital Anxiety Depression scale - Anxiety subscale),
impact of vusial impairment (measured with the Impact of Visual Impairment
questionnaire, IVI), work functioning (measured with the Work Functioning
Questionnaire-2.0), need for recovery (measured with the Need for Recovery
questionnaire), trouble sleeping (measured with the Holland Sleep Disorders
Questionnaire), health care utilisation (measured with the Health care
utilisation and medication use (iMTA Medical Costs Questionnaire), absence and
presenteeism from paid and unpaid work (measured with the Absenteeism and
presenteeism (iMTA Productivity Cost Questionnaire), and quality-adjusted life
years are determined with the Euroqol 5 Dimensions 5 levels.
Process evaluation (i.a. feasibility study):
Cognitive therapy skills are measured with the Competencies of Cognitive
Therapy Scale-Self Report (CCTS-SR) of which two versions will be used: a
patient and a therapist version. Compliance is measured by patients rating
their effort and social workers rating patients* compliance to the E-nergEYEze
intervention, based on a 10-point scale. The intervention platform Minddistrict
logs how often and for how long they used the intervention. Recall is measured
by social workers rating the degree to which patients seem to remember last
modules on a 10-point scale. Patient satisfaction with the intervention is
measured with the Dutch Mental Healthcare (MH) thermometer of satisfaction.
Therapist satisfaction and adherence is measured by means of evaluation forms
filled out by social workers during the intervention.
Working mechanism:
The 7-item Brief Illness Perceptions Questionnaire is used to assess
perceptions and beliefs about fatigue, the Self-efficacy scale to assess how
fatigue is handled and the Fatigue Catastrophizing Scale to assess negative
cognitions towards fatigue in addition the Adaption to vision loss (AVL)and
PHQ, and the CCTS-SR, but also patient characteristics such as severity of
vision loss (blind or partially sighted) and visual field loss, eye condition,
stable vs progressive eye disease, living alone or with others, work
participation, financial situation.
Background summary
Results from our former study show that 57% of visually impaired adults have
severe symptoms of fatigue, which is at least twice as high as in the general
Dutch population. Having disabling fatigue in addition to visual impairment, is
associated with incremental societal costs that largely determine the economic
burden of low vision through increased healthcare utilization and reduced work
participation. Previous research showed that e.g. accommodative coping
strategies, depressive symptoms, the cognitive effort needed for visual
perception and hindrance of light are associated with fatigue in people with
visual impairment. Unlike for some other chronic diseases, effective treatment
options for fatigue have not been developed for the visually impaired. Although
clients have indicated that reducing fatigue is a rehabilitation goal of high
importance, professionals from Dutch rehabilitation services have acknowledged
this to be a major gap in their knowledge, skills and treatment options.
Study objective
The objective of the study is to develop and test a blended vision-specific
E-health-based cognitive behavioral & self-management intervention (*E-
nergEYEze*). Our specific goals are: (1) to further develop E-nergEYEze for
visually impaired adults; (2) investigate its usability and feasibility; (3)
study the effectiveness of E-nergEYEze compared with care as usual in a
randomized controlled trial in reducing fatigue severity; (4) investigate
cost-effectiveness and cost-utility from a healthcare and societal perspective;
(5) investigate fidelity and intervention uptake with a process evaluation; (6)
the working mechanisms ,which might be the psychological mechanisms, such as
self-efficacy, illness perceptions and beliefs and negative cognitions towards
fatigue that might explain whether the intervention is effective in subgroups
of patients with a structural equation model and (7) to Investigate the
association between cognitive overload and fatigue based on screening data and
what factors confound or mediate this association (i.e. motivation, activity,
demographic and disease specific characteristics).
Study design
After the blended self-management intervention has been tested in a usability
(N=5) and feasibility study (N=10) to ensure applicability and to increase
implementation chances, a pragmatic single blinded randomized controlled trial
(N=172) will be performed, stratified by the rehabilitation service region and
employment status.
Intervention
The blueprint of E-nergEYEze contains an introduction module plus eight
thematic modules: (a) understanding vision-related fatigue; (b) experiencing
visual impairment and coping; (c) helping, fatigue reducing thoughts; (d)
distribute and build up activities; (e) communication and social support; (f)
stress and relaxing; (g) optional: improving sleep; (h) optional: work
optimization; (i) the future. E-nergEYEze is guided by social workers via a
one-hour face-to-face start session, digital (appr. 3 hrs) and telephone
contacts (2 times appr. 30-60 min), with a one-hour specific professional
computer training. The intervention takes five months and E-nergEYEze will be
compared to care as usual, which is any care a patient needs from the low
vision services or other care services.
Study burden and risks
Participating in this study is with minimally exceeding negligible risk. We
expect that the burden of E-nergEYEze will be acceptable. The focus is on
helping patients with symptoms of fatigue in adaption to vision impairment.
However, it is possible that the intervention will cause 'advers effects',
causing the symptoms to worsen. In that case the general practitioner is
immediately contracted. Moreover, participation is voluntary and participants
may drop-out at any time.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Inclusion criteria
Inclusion criteria:
- visually impaired according to WHO criteria + guidelines of rehabilitation
center, of any cause (eye condition); moderate visual impairment or worse and,
in consultation with the research team, a progressive mild visual impairment.
- 18 years or older
- understanding of the Dutch language
- experiencing severe fatigue (CIS-score>35)
- having home access to internet
Exclusion criteria
Exclusion criteria:
- severe cognitive limitations assessed with the 6-item screener (short
validated Mini Mental State Examination).
- currently receiving treatment, or having received treatment in the last 12
months for comorbid disease that clearly is the main cause of fatigue (e.g. MS,
cancer, psychiatric disorder).
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 | NL67802.029.18 |
| OMON | NL-OMON28085 |