To evaluate measurement properties and feasibility of the self-report Northwestern Ego-Integrity Scale in patients with ALS (or its variants PMA and PLS)
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ego-integrity as measured by the Northwestern Ego-Integrity Scale (NEIS). The
NEIS is a self-reported, 15 item questionnaire measuring ego-integrity and
despair, with higher mean scores indicating more despair and ego-integrity.
Secondary outcome
Psychological distress assessed with the Hospital Anxiety and Depression Scale
(HADS): The HADS is a 14 items questionnaire which measures depression and
anxiety. This questionnaire is specifically validated for patients with a
(chronic) disease. The HADS consists of two subscales: HADS-D (7 items)
measuring depression and HADS-A (7 items) measuring anxiety. Higher scores
reflect more anxiety and/or depressive symptoms.
Illness cognitions assessed with the Dutch questionnaire "Ziekte Cognitie
Lijst" (ZCL): The ZCL consists of 3 subscales: helplessness (6 items),
acceptation (6 items) and disease benefits (6 items). The scores per scale
range from 6-24.
Sense of hope assessed with the Dutch version of the Herth Hope Index (HHI), a
short (12 item) questionnaire that assesses the cognitive, affective,
behavioral, temporal, and contextual dimensions of hope.
Background summary
Receiving a diagnosis of MND is challenging for patients and their families and
represents an existential shock. Most ALS-patients show resilience but in some
patients the prospect of loss of physical abilities and early death can result
in despair, depression and hopelessness. The Northwestern Ego-Integrity Scale
was developed to measure ego-integrity and despair, and may be a valid
instrument in patients with ALS.
Study objective
To evaluate measurement properties and feasibility of the self-report
Northwestern Ego-Integrity Scale in patients with ALS (or its variants PMA and
PLS)
Study design
To evaluate reliability, participants will fill in the Northwestern
Ego-integrity Scale (NEIS) twice with one week in between. Test-retest
reliability will be assessed by the intraclass correlation coefficient (ICC),
and the measurement error (expressed as SEM and limits of agreement).Construct
validity will be assessed by the degree to which the NEIS domain scores
(ego-integrity and despair) are consistent with predefined hypotheses regarding
relationships with other measures of related constructs (Anxiety, depression,
hope, illness cognitions).
Study burden and risks
Participants will be asked to fill in questionnaires of which the NEIS is
completed twice for reliability purpose. Two of these questionnaires (HADS and
ZCL) are currently used in ALS-care practice. Patients will be able to complete
the questionnaires at home. No significant physical or psychological discomfort
can be expected. There are no risks associated with study participation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of ALS, Progressieve Spinal Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)
Currently under the care of a rehabilitation specialist
-No cognitive impairments as judged by the rehabilitation specialist of the patient
-Documented score on the ALSFRS-R
-Sufficient fluency in the Dutch language to complete study questionnaires
-Aged 18 years or older
Exclusion criteria
- If the patient has received the diagnosis less than 6 months ago
- Diagnosis of frontotemporal dementia
- Other life-threatening diagnosis or patients who are in the finale stage of the disease
Design
Recruitment
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 | NL62688.018.17 |