Primary objective:What is the effectiveness of the PARASOL intervention on impact of symptoms and physical and mental dimensions of quality of life in patients with moderate MUPS compared with usual care?Secondary Objectives: 1. What is the…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
patiënten met uiteenlopende somatisch onvoldoende verklaarde lichamelijke klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life, measured with the RAND-36 health survey
Impact of symptoms measured with the adequate relief question
Secondary outcome
- Severity of symptoms, defined as self-perceived pain and fatigue in the past
week, will be measured with an 11-point numeric scale (score 0-10)
- Severity of psychosocial symptoms will be measured with 4DKL questionnaire.
- Health care use and indirect costs through illness and absenteeism will be
measured with TIC-P questionnaire to evaluate cost-effectiveness in terms of
costs per *Quality Adjusted Life Years (QALYs)
- Physical behaviour will be measured with the Activ8 activity monitor. The
Activ8 is a valid measurement in detecting lying/sitting, standing, walking,
running and cycling.
- Measure of perceived health will be more specifically measured with the EQ5D
questionnaire.
- Self-efficacy will be measured with the Hei-Q questionnaire
- Illness perceptions will be measured with the Brief Illness Perception
Questionnaire.
- Efficacy, barriers and facilitators of the PARASOL intervention according to
participating subjects and professionals will also be determined, using the
*System Usability Scale (SUS)*. The SUS will be completed at T1, at the end of
the PARASOL program.
Background summary
Medically unexplained physical symptoms (MUPS) are a serious problem in primary
care, with a spectrum from mild to moderate or chronic MUPS. The burden of
chronic MUPS is substantial for patients, health care professionals and the
society. Therefore, early identification of patients with moderate MUPS to
prevent chronicity is needed. Recently a new screenings method with acceptable
prognostic accuracy was developed using data from the electronic medical record
of the general practitioner. Furthermore, we developed a proactive blended and
multidisciplinary preventive intervention to reduce complaints of moderate MUPS
and to prevent chronicity, called the PARASOL intervention. The expectation is
that this blended care will promote self-management. However, the
(cost)effectiveness of this PARASOL intervention needs to be established. It is
hypothesised that the PARASOL intervention, focused on modifiable prognostic
risk factors of chronic MUPS in which principles of the modified consequence
model, central sensitisation, cognitive behavioural approach and graded
activity are integrated, can reduce impact and severity of symptoms and
increase quality of life, general health, physical behaviour, illness
perception and self-efficacy in patients with moderate MUPS.
Study objective
Primary objective:
What is the effectiveness of the PARASOL intervention on impact of symptoms and
physical and mental dimensions of quality of life in patients with moderate
MUPS compared with usual care?
Secondary Objectives:
1. What is the influence of the PARASOL intervention on severity of symptoms,
general health, physical behaviour, illness perception and self-efficacy in
patients with moderate MUPS compared with usual care?
2. What is the cost-effectiveness of the PARASOL intervention in patients with
moderate MUPS compared with usual care?
Study design
cluster randomized clinical trial
Intervention
Subjects of the experimental health care centers will follow the PARASOL
intervention. The PARASOL intervention will take 12 weeks with:
4 sessions with the mental health nurse (30 minutes per sessions)
5 sessions with the physical therapist (30 minutes per sessions)
Total of 4.5 hours
Weekly online modules: duration of 1-1.5 hour weekly (max 12-18 hours)
Study burden and risks
Benefits:
Subjects randomized in the PARASOL intervention can have beneficial effects of
the intervention on their experienced quality of life, severity of symptoms and
adequate relief. There are no benefits of participation during the study for
subjects randomized in the control group. However, subjects of the control
group will be offered the complete PARASOL intervention or only the online part
of the PARASOL intervention after the last follow-up measurement, twelve months
after completing the baseline measurements.
Risks:
The study is carried out with adults. The risks for the subjects are minimal
because of the low burden of the intervention for the subjects in the
experimental group. Additionally, the subjects in the experimental group will
not impose any kind of restrictions. The focus in the PARASOL intervention will
be on modifiable prognostic risk factor of chronic MUPS through graded
activity, coaching using face-to-face contact and an eHealth module, based on
current literature, guidelines and focus groups with experts. Additionally,
there are also no risks or any kind of restrictions for the subjects in the
control group, since they will receive care as usual. The duration of the
sessions with the physical therapist and mental health nurse will take 30
minutes per session. The duration of the online part of the PARASOL
intervention will take one hour weekly. Filling in questionnaires at baseline,
after three and twelve months will take 30-45 minutes. The adequate relief
question will be completed more often and will take a maximum of 5 minutes each
time. The adequate relief question will be completed weekly between T0 and T1,
and monthly between six and twelve months after baseline. Subjects will also
complete the questionnaire on health care use and indirect costs six and nine
months after baseline, which will take approximately 15 minutes.
Additionally, subjects have to wear the Activ8 activity monitor to measure
physical behaviour at baseline, after three and twelve months for one week. The
Activ8 will be worn for three weeks totally. Wearing the Activ8 activity
monitor has a low burden since the Activ8 can be worn in the pants pocket and
does not have to be recharged during the week.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Subjects will be selected and identified with the PRESUME screening method.
In order to be eligible to participate in this study, a subject must meet all of the following criteria; the subjects have to:
- be 18 years or older
- not suffering from chronic somatic or psychiatric disease
- have five or more consultations with the GP in the past twelve months of which at least three of those consultations are with one of the 104 ICPC codes suggestive of MUPS.;Health care centers in primary care are eligible to participate if all relevant disciplines (general practitioner, physical therapist, mental health nurse) are available and willing to participate.
Exclusion criteria
Eligible subjects will be excluded when the subject has:
- insufficient mastering of the Dutch language
- no access to the internet.;Furthermore, all identified subjects using the PRESUME screening method will be screened by their GP. Subjects identified with moderate MUPS will be excluded if one or more of the following criteria apply:
- received a medical explained diagnosis between identification using the PRESUME method and the time of inclusion.
- complaints with a shorter duration than one month, in which more diagnostic evaluation of the symptoms is needed.
- unable to participate according to the GP, f.i. because of a life threatening condition, a short life expectancy, an experienced life event in the past month or a subject had followed a multidisciplinary intervention in the past 12 months.
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 | NL57931.041.16 |