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Clinical Course of Patients Receiving Physiotherapy Services in Primary Health Care (FYSIOPRIM)

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ClinicalTrials.gov Identifier: NCT03626389
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Norwegian Fund for Postgraduate Training in Physiotherapy
Norwegian University of Science and Technology
Trondheim Kommune
Information provided by (Responsible Party):
Nina K. Vollestad, University of Oslo

Brief Summary:

Background: Physiotherapists (PTs) in primary health care manage patients with a large variation in medical diagnosis, age, functional status, disability and prognosis. Lack of knowledge and systematically collected data about patients treated by PTs in primary health care has prompted this longitudinal observational physiotherapy project in Norway. This paper aims to describe a method for developing a database of patients managed by PTs in primary health care to study patients' characteristics, treatment courses and prognostic factors.

The study is a longitudinal observational project, following patients through physiotherapy treatment periods in primary health care in Norway and until one year after inclusion. The project involves both private practice and municipally employed PTs working in primary health care in eight municipalities in Norway. The participants are recruited to three different parts of the project depending on age and whether they are referred to a private practice or a municipally employed PT. All data are recorded electronically, transferred and stored securely. All patients complete extensive questionnaires providing information about demographics, disability and function, pain related variables, treatment and evaluation of treatment as well as clinical tests. The PTs have access to their own patients' data. The investigators have also prepared for linkage to national patient registers and population-based studies to be able to gather further important data.

This project will have important implications for physiotherapy services in primary health care. The database already contains almost 3000 patients, and data collection is ongoing. Preliminary analyses suggest that the patients included so far are representative of the larger population of patients treated by private practice or municipally employed PTs in Norway. This large scale prospective physiotherapy project will provide knowledge about the patient groups treated, treatment given as well as short and long term outcome of the patients.


Condition or disease Intervention/treatment
Musculoskeletal Diseases or Conditions Neurologic Disorder Widespread Chronic Pain Psychosomatic Disorder Arthritis Injuries Other: Physiotherapy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Course and Prognostic Factors of Patients Receiving Physiotherapy Services in Primary Health Care in Norway (FYSIOPRIM)
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Group/Cohort Intervention/treatment
Patients receiving physiotherapy
Physiotherapy, without predetermined selection of specific modalities
Other: Physiotherapy



Primary Outcome Measures :
  1. Change in Health-Related Quality of LIfe - assessed by EuroQual 5 Dimensions questionnaire (EQ-5D) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Utility measure of Health related quality of life. Range -0.59 (worst) to 1 (best)

  2. Change in Patient-Specific Functional Scale (PSFS) [ Time Frame: Baseline, 1, 3, 6 and 12 months ]
    Participants identify activities that are difficult to perform and scores them from 0 (cannot perform) to 10 (perform without problems)

  3. General Perceived Effect [ Time Frame: 3, 6 and 12 months ]
    A global assessment of change- 7 level scale. Score range 1 (very much better) to 5 (very much worse)

  4. Change in Pain intensity [ Time Frame: Baseline, 1, 3, 6 and 12 months ]
    Pain intensity assessed by a numeric rating scale. Range 0 (no pain) to 10 (worst imaginable)


Secondary Outcome Measures :
  1. Change in Work participation [ Time Frame: Baseline, 3, 6 and 12 months ]
    Sick leave (% of full time)

  2. Change in work ability [ Time Frame: Baseline, 3, 6 and 12 months ]
    One questeion. Range 0 (cannot work at all) -10 (can work at my very best)

  3. Change in pain distribution [ Time Frame: Baseline, 3, 6 and 12 months ]
    Participants marks pain distribution in a drawing- max no of sites:112

  4. Change in use of analgesics containing paracetamol [ Time Frame: Baseline, 3, 6 and 12 months ]
    Participants indicate if used last week and how often (less than daily, 1-4 per day, >5 per day)

  5. Change in use of analgesics containing ibuprofen [ Time Frame: Baseline, 3, 6 and 12 months ]
    Participants indicate if used last week and how often (less than daily, 1-4 per day, >5 per day)

  6. Change in use of analgesics containing acetylsalicylacid [ Time Frame: Baseline, 3, 6 and 12 months ]
    Participants indicate if used last week and how often (less than daily, 1-4 per day, >5 per day)

  7. Change in emotional distress assessed by Hopkins Symptoms Check List (HSCL) [ Time Frame: Baseline, 3, 6 and 12 months ]
    10 questions. Score range: 1 (best) to 4 (worst)

  8. Change in Pain Self-efficacy [ Time Frame: Baseline, 3, 6 and 12 months ]
    Pain Self-efficacy Questionnaire (2 items). Score range 0 worst) to12 (best)

  9. Change in health related quality of life assessed by 15D [ Time Frame: Baseline, 3, 6 and 12 months ]
    Utility merasure of Health related quality of life - range 0 (worst) to 1 (best)

  10. Change in catastrophising thoughts assessed by Pain Catastrophizing Scale [ Time Frame: Baseline, 3, 6 and 12 months ]
  11. Change in Neck disability Index (NDI) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Questionnaire - Score range 0 (best) to 100 (worst)

  12. Change in Oswestry Disability Index (ODI) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Questionnaire - Score range 0 (best) to 100 (worst)

  13. Change in Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Questionnaire for patients with shoulder pain - Range 0 (no disability) to 100 (completely disabled)

  14. Change in Disability of the Arm, Shoulder and Hand score (Quick-DASH) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Questionnaire for patients with shoulder or arm pain - Range 0 (no disability) to 100 (completely disabled)

  15. Change in temporal aspects of pain [ Time Frame: Baseline, 3, 6 and 12 months ]
    Participants responds with yes/no to questions on continual pain and variability in pain intensity

  16. Change in hip disability - assessed by the Hip Disability and Osteoarthritis Outcome Score (HOOS) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Hip disability questionnaire for patient with hip pain - 5 domains (pain, symptoms, ADL, sports/recreation, quality of life). Score range 0 (best) -100 (worst)

  17. Change in pelvic girdle pain and disability assessed by the Pelvic Girdle Questionnaire [ Time Frame: Baseline, 3, 6 and 12 months ]
    Quesionnaire questionnaire for patient with pelvic girdle pain - range 0 (no disability or pain) to 100 (high disability and pain)

  18. Change in knee disability - assessed by the Knee Disability and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Knee disability questionnaire for patient with knee pain - 5 domains (pain, symptoms, ADL, sports/recreation, quality of life). Score range 0 (best) -100 (worst)

  19. Change in physical functioning assessed by the Physcal function domain of Short Form 36 - (SF-36) [ Time Frame: Baseline, 3, 6 and 12 months ]
    Sumscore with range 0 (worst) to 100 (best)

  20. Change in insomnia problems assessed by the Insomnia Severity Index [ Time Frame: Baseline, 3, 6 and 12 months ]
    Questionnaire - score range 0 (no insomnia problems) to 28 (severe insomnia problems)

  21. Change in 6 min walk [ Time Frame: Baseline, 3, 6 and 12 months ]
    6 min walk - timed measure (s)

  22. Change in stair climb capacity [ Time Frame: Baseline, 3, 6 and 12 months ]
    Stair climb 3 flights - up and down; timed measure (s)

  23. Change in physical capacity assessed by 30 s sit to stand [ Time Frame: Baseline, 3, 6 and 12 months ]
    Assessed as the number of times to complete a sit to stand and sit cycle witin 30 s

  24. Short Physical Performance Battery [ Time Frame: Baseline, 3, 6 and 12 months ]
    4 tests of Physical performance

  25. Fulfilment of expectations [ Time Frame: 3, 6 and 12 months ]
    One question

  26. Benefit of treatment [ Time Frame: 3, 6 and 12 months ]
    One question

  27. Fulfillment of treatment goals [ Time Frame: 3 months ]
    patients evaluate if the individually defined treatment goals are met, partially met or not met at all



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 125 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients are recruited through physiotherapists in primary health care.
Criteria

Inclusion Criteria:

  • any patient seeking or receiving physiotherapy services in primary health care

Exclusion Criteria:

  • Not understanding Norwegian or English language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626389


Contacts
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Contact: Nina N Vollestad, PhD +4722845377 nina.vollestad@medisin.uio.no

Locations
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Norway
Approx 100 physiotherapists in Norway Recruiting
Oslo, Norway
Contact: Hilde S Robinson, PhD       h.s.robinson@medisin.uio.no   
Principal Investigator: Hilde S Robinson, PhD         
Sub-Investigator: Nina K Vøllestad, PhD         
Sub-Investigator: Wenche S Bjorbækmo, PhD         
Physiotherapists in Trondheim Recruiting
Trondheim, Norway
Contact: Ottar Vasseljen, PhD       ottar.vasseljen@ntnu.no   
Principal Investigator: Ottar Vasseljen, PhD         
Sub-Investigator: Kari AI Evensen, PhD         
Sub-Investigator: Ingebrigt Meisingset, PhD         
Sub-Investigator: Astrid Woodhouse, PhD         
Sponsors and Collaborators
University of Oslo
Norwegian Fund for Postgraduate Training in Physiotherapy
Norwegian University of Science and Technology
Trondheim Kommune
Investigators
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Principal Investigator: Nina K Vøllestad, PhD University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nina K. Vollestad, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03626389     History of Changes
Other Study ID Numbers: FYSIOPRIM
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to make the data available for other researchers. Anonymous data will be shared to all that asks and that provide a research plan approved by our steering committee. We will in principle be open for sharing all data, but we also need to verify that we comply with the approvals given. Deidentified data may be shared with other researchers given that they have secure storage and analytical platforms.
Time Frame: We plan to share data from 1 January 2019 and until our approval for use of data expires.
Access Criteria: Quality of proposal Scientific publication required as output to researchers Reports or white papers required as output to managers Financial support to carry out the project No conflict with ongoing research based on the data The use is in keeping with research ethical standards and regulations for use of personal data
URL: http://www.med.uio.no/helsam/english/research/groups/fysioprim/index.html
Keywords provided by Nina K. Vollestad, University of Oslo:
physiotherapy
primary health care setting
Additional relevant MeSH terms:
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Disease
Chronic Pain
Psychophysiologic Disorders
Somatoform Disorders
Musculoskeletal Diseases
Nervous System Diseases
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Mental Disorders