The study has two objectives:1) Is chronic fatigue a clinically relevant issue in patients with DM type 1?Chronic fatigue will be considered a clinically relevant issue if:(a): the proportion chronically fatigued DM type 1 patients is at least 25%(b…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1a) Fatigue severity will be assessed using the fatigue subscale of the
Checklist Individual Strength (CIS) a widely used, reliable and well-validated
instrument. The fatigue subscale of the CIS consists of 8 items scored on a 7
point Likert scale (8-56). A cut-off score of 35 or higher is an indication for
severe fatigue. Chronic fatigue is defined as scoring 35 or higher and
indicating that fatigue lasted 6 months or longer.
1b Functional impairments will be assessed with the Sickness Impact Profile
(SIP-8). The SIP-8 assesses impairments on eight domains of functioning: mental
functioning, sleep/rest, work limitations, homemaking, leisure activities,
mobility, social interactions and ambulation. A total score on the SIP-8 higher
than 700 is an indication for substantially impaired daily functioning.
1c) Patients will be asked whether they have experienced 36 different
symptoms, including fatigue in the past month. If the symptom did occur
patients are asked to indicate how troublesome the symptom was on a five point
scale from 1 (not at all) to 5 (extremely). The mean will be calculated over
how troublesome symptoms were and means will be ranked.
2) - Diabetes self-care behaviours: Diabetic Self-Care Inventory (CIDS) and
Diabetic-related distress (Problem areas in diabetes scale (PAID))
-Fatigue related cognitions and behaviours: Self-efficacy concerning fatigue
(Self-efficacy Scale (SES-26)), focusing on fatigue (Illness Management
Questionnaire (IMQ)), catastrophising concerning fatigue (JFCS), Physical
activity (VLA), somatic attributions concerning fatigue (CAL)
Blood glucose variability: A subgroup of patients (n=100) will be asked to use
a continuous blood glucose monitor (CGM) to determine blood glucose levels
every few minutes for a period of 5 days. A CGM system consists of a disposable
glucose sensor placed just under the skin, and an electronic receiver. Blood
glucose variability will be determined by calculating the standard deviation of
the blood glucose levels over the 5 days.
Physical activity will be assessed in a subgroup of patients (n=100) with
actigraphy using an actometer. An actometer is a motion sensing device. The
actometer has the size of a matchbox and is worn around the ankle for 12
consecutive days and nights. It records the number of movements at five-minute
intervals. The mean daily physical activity score across twelve days and night
will be determined to assess the level of physical activity.
Secondary outcome
The level of fatigue will be assessed in non-responders using a set of three
questions (vermoeidheidsvragenlijst, VVV).
Background summary
It is estimated that about 85.000 people have diabetes mellitus type 1 (DM type
1) in the Netherlands. In clinical practice fatigue is a commonly reported
symptom by patients with DM type 1. However, fatigue in DM type 1 has never
been studied systematically. Data on fatigue in patients with DM type 2 suggest
that a substantial number of patients report fatigue. Acute elevations of blood
glucose can lead to tiredness, and both hypo- and hyperglycemia were associated
with fatigue. Suboptimal diabetes self-care behaviours, were also related to
fatigue. In clinical practice DM patients can be chronically fatigued although
blood glucose levels are stable. This suggests that other variables beside
blood glucose play also a role.
It is important to differentiate between acute and chronic fatigue. Chronic
fatigue is often defined as being severely fatigued for at least 6 months.
Research in patients with other chronic illnesses showed that a substantial
proportion of patients are chronically fatigued. This chronic fatigue is
associated with more severe disabilities. It is likely that chronic fatigue
also occurs often in patients with DM type 1 and will be associated with more
impairments in daily functioning.
Research in other chronic illnesses also showed that other factors than the
illness itself can perpetuate fatigue. Specifically cognitive and behavioural
factors seem to play a crucial role in the perpetuation of chronic fatigue.
Examples of these factors are a low self-efficacy with respect to fatigue,
catastrophising in response to the fatigue, a disrupted sleep-wake cycle and a
reduced level of physical activity. On the basis of these findings cognitive
behavioural interventions were developed that demonstrated that by changing
fatigue perpetuating cognitions and behaviours, chronic fatigue can be
effectively treated. The reduction of fatigue led to a decrease of functional
impairments and an improved quality of life.
If chronic fatigue is a clinically relevant problem in DM type 1 it is
important to investigate to what extent chronic fatigue in DM type 1 is
associated with the aforementioned fatigue perpetuating cognitions and
behaviours. If this is the case, this would imply that a cognitive behavioural
intervention might be an effective treatment for chronic fatigue in patients
with DM type 1.
Study objective
The study has two objectives:
1) Is chronic fatigue a clinically relevant issue in patients with DM type 1?
Chronic fatigue will be considered a clinically relevant issue if:
(a): the proportion chronically fatigued DM type 1 patients is at least 25%
(b): it is associated with impaired daily functioning
(c): if chronically fatigued patients rank fatigue as one of the three most
troublesome symptoms.
2) Which factors are significantly associated with chronic fatigue in patients
with DM type 1? More specifically:
Are diabetic self-care behaviours, glucose variability and fatigue perpetuating
cognitions and behaviours significantly associated with fatigue?
Study design
This is an observational study (cohort study).
Three hunderd fifty patients will be randomly selected from the visitors of the
outpatient diabetes clinic of the Radboud University Nijmegen Medical Centre.
It is expected that two hundred patients will participate in the proposed study
(questionnaires). In a subgroup of one hundred patients glucose variability
and the level of physical activity will be assessed.
Study burden and risks
Participants have to complete questionnaires. This is without risks. These can
be completed online or a paper and pencil version will be send to the
participant. It will take about a half hour to complete the questionnaires. If
patients participate in the whole study they will wear a continues glucose
monitor (CGM) for 5 days. The risks using the CGM are small, utmost there is a
risk for a local infection in the area where the needle is placed. Patients
will also be asked to were an actometer, a motion sensing device, which will be
worn around the ankle for two weeks. There are no risks involved using the
actometer.
Toernooiveld 214, Mercator I
6525 EC Nijmegen
NL
Toernooiveld 214, Mercator I
6525 EC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients with diabetes mellitus type 1
DM type 1 diagnosed at least one year previously
Being 18 years of age or older.
Being able to read and write and understand Dutch
Exclusion criteria
no additional criteria
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 | NL35495.091.11 |