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Evaluation of a proactive preventive program in patients with medically unexplained physical symptoms.

Evaluation of a proactive preventive program in patients with medically unexplained physical symptoms. - PARASOL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46266
Enrollment
248
Registered
2017-06-07
Start date
2017-03-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patiënten met uiteenlopende somatisch onvoldoende verklaarde lichamelijke klachten Medically Unexplained Physical Symptoms

Interventions

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 sessio
intervention
multidisciplinary
MUPS

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Quality of life, measured with the RAND-36 health survey Impact of symptoms measured with the adequate relief question

Secondary

MeasureTime frame
- 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.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)