Active@Work - Optimizing Physical Activity at Work.
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip; Physical Activity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The aim of this project is to explore if monitoring physical activity including feedback can
      have any effect on physical activity level, function, work ability, health related quality of
      life or work productivity among individuals with hip and/or knee osteoarthritis. This will be
      performed by evaluating the use of mobile technology and activity monitoring to support
      physical activity in individuals with OA in a cluster randomized controlled trial. The
      investigators research questions are:

      • Can an intervention, comprised of the above mentioned technology, have any effect on
      physical activity level, function, work ability, quality of life or work productivity among
      individuals with OA?
    

Detailed description: 
      Methods Design and setting The project will be performed as a cluster randomized controlled
      intervention study within primary health care in the region of Skåne and Halland.

      Sample Patients who are referred to the patient education program for OA in primary health
      care will be invited to participate in the project. Participants will also be recruited using
      advertisement on social media. Participants recruited from social media will attend the
      patient education program for OA arranged by this project.

      There will be one control group and one intervention group, see details below:

      A. Patient education program and physical activity monitoring. C. Patient education program
      (control).

      Each group within the patient education program for OA will be randomized to either group A
      or group C. Patients that fulfil the inclusion criteria will then be asked to participate.
      Digital (BankID or e-legitimation) informed consent will be obtained at the project's
      website. Recruitment of participants in intervention group A and control group C starts in
      autumn 2017 and continues through spring 2019 or when sufficient numbers of participants have
      been included.

      Interventions Activity monitoring will be performed by giving each participant in group (A) a
      wearable sensor (Fitbit Flex 2), where the daily physical activity level will be recorded.
      The monitoring will start at the patient education program within BOA. All activity monitors
      will be programmed with a daily goal of 7 000 steps. The participants will have the
      opportunity to follow their physical activity through the fitbit app were they also will
      receive standardised feedback. The intervention will be performed during three months, with
      follow-ups online after 3, 6 and 12 months.

      Measures Patient-reported outcomes

      Participants will answer the following questionnaires at baseline, after the intervention (3
      months) and 6 and 12 months after baseline. Measurements will include:

        -  Self-rated work ability (Work ability Index, Ilmarinen,2007)

        -  Self-rated work productivity (WPAI-OA, Legget et.al.,2016)

        -  Self-rated health-related quality of life (EQ-5D) (http://www.euroqol.org/)

        -  Self-rated function in relation to hip and knee arthrosis (HOOS, Nilsdotter 2003, KOOS,
           Paradowski 2006).

        -  Self-rated physical activity (IPAQ, Craig et.al.2003).

        -  Questions about the work environment and physical activity.

      Statistics The investigators will recruit approximately 80 participants/group. With this
      sample size and 80 % power, effect sizes of about 0.45 SD (significance level 5%) can be
      identified. In terms of WAI, this corresponds to SD 6, approximately 2,7 points
      increase/higher score in the intervention group, compared to the control group. Compliance
      with the intervention will comprise of the activity monitoring device used on at least 50% of
      the work days. With relatively large group sizes and most data expected to a follow an
      approximately normal distribution, group differences in the development over time with
      respect to the different outcome variables will be analyzed by ANOVA models (repeated
      measures or cross sectional comparison of mean difference scores). Some outcome variables,
      may likely be skewed and hence appropriate transformations, or non-parametric models, will be
      applied. Final and exact analytical strategies will be decided once data is available for
      exploration of final group sizes and distributions/symmetry of numeric outcome variable data.
    

Intervention name(s): FitBit Flex 2
Intervention type(s): Device
Intervention description(s): Participants in the intervention Group will wear the FitBit Flex 2 for Three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-Randomized controlled trial
Masking: Single (Investigator)
Primary purpose: Treatment