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Evaluation of a proactive program to prevent chronic pain, fatigue and/or dizziness


- candidate number28013
- NTR NumberNTR6755
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-okt-2017
- Secondary IDs16/532  METC
- Public TitleEvaluation of a proactive program to prevent chronic pain, fatigue and/or dizziness
- Scientific TitleEvaluation of a proactive preventive program in patients with medically unexplained physical symptoms
- ACRONYMPARASOL
- hypothesisMedically unexplained physical symptoms (MUPS) are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic MUPS is substantial for patients, health care professionals and society. We developed a proactive blended and multidisciplinary preventive intervention to reduce complaints of moderate MUPS and to prevent chronicity, called the PARASOL intervention. It is hypothesised that the PARASOL intervention 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.
- Healt Condition(s) or Problem(s) studiedMedically unexplained physical symptoms (MUPS)
- Inclusion criteria- ≥18 years,
- ≥5 general practice consultations during the past twelve months
- mastering of the Dutch language
- access to the internet.
- Exclusion criteriaNot applicable.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-mrt-2017
- planned closingdate1-jun-2019
- Target number of participants248
- InterventionsThe PARASOL intervention is a 12-week blended primary care program consisting of four face to face consultations with the mental health nurse and five sessions of physical therapy, supplemented with a web-based program.

The control group will get care as usual without any restrictions.
- Primary outcomeimpact of symptoms and quality of life
- Secondary outcomeseverity of symptoms, general health, physical behaviour, illness perceptions, self-efficacy and cost-effectiveness
- TimepointsThree moments (0, 3 and 12 months) will be used for data collection. In addition, cost questionnaires will also be sent at 6 and 9 months. Furthermore, impact of symptoms will be measured weekly between 0 and 3 months, and monthly between 6 and 12 months.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc, PT. P.E. (Els) Westrienen, van
- CONTACT for SCIENTIFIC QUERIESMSc, PT. P.E. (Els) Westrienen, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
SIA-RAAK
- Publications
- Brief summary1. Background
Medically unexplained physical symptoms (MUPS) are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic MUPS is substantial for patients, health care professionals and society. Therefore, early identification of patients with moderate MUPS is needed, enabling prevention of chronicity. We developed the PRESUME screenings method using data from the electronic medical record of the general practitioner and demonstrated its prognostic accuracy to identify patients with moderate MUPS. In the next step we developed a proactive blended and integrated mental health and physiotherapy intervention program (PARASOL), to reduce complaints of moderate MUPS, stimulate self-management and prevent chronicity. The primary objective of this study is to investigate the effectiveness of the blended PARASOL intervention on the impact of symptoms and quality of life in patients with moderate MUPS compared with usual care.

2. Research questions
1. 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?
2. 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?
3. What is the cost-effectiveness of the PARASOL intervention in patients with moderate MUPS compared with usual care?

3. Study design
We will perform a multicenter cluster randomized clinical trial. Adult patients with moderate MUPS will be identified in electronic medical record data using the PRESUME screening and proactively recruited for participation in the study. Cluster randomization will be performed at the level of the participating health care centers. In total 248 patients with moderate MUPS (per arm 124 patients) are needed. The PARASOL intervention is a 12-week blended primary care program consisting of four face to face consultations with the mental health nurse and five physiotherapy sessions, supplemented with a web-based program. The web-based program contains of (1) information modules and video’s on self-management and educative themes, (2) video’s and instructions on prescribed home exercises and (3) assignments to gradually increasing physical activity program. The program is directed at patients’ perception of symptoms, and modifiable prognostic risk factors for chronicity using therapeutic neuroscience education and encouraging self-management as well as an active lifestyle using a cognitive behavioural approach and graded activity. Primary outcomes are impact of symptoms and quality of life. Secondary outcomes are severity of (psychosocial) symptoms, general health, physical behaviour, illness perceptions, self-efficacy and cost-effectiveness. All measurements will be performed at baseline, three and twelve months after baseline. Retrospective cost questionnaires will also be sent at six and nine months after baseline, used for the cost- effectiveness analysis.
- Main changes (audit trail)
- RECORD13-okt-2017 - 11-nov-2017


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