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Trial record 2 of 388 for:    Ankylosing Spondylitis

Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).

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ClinicalTrials.gov Identifier: NCT03457285
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Salaso Health Solutions Limited
Novartis
Information provided by (Responsible Party):
Ciaran Brennan, St. James's Hospital, Ireland

Brief Summary:
This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. All individual exercises and exercise class videos will be available on the app. Completion of exercises can be logged on the app and exercise compliance will then be monitored remotely by the physiotherapist through the Salaso app. The physiotherapist will have a monthly telehealth session with each participant to assess progress and to address any difficulties. Outcome measures will be completed at initial assessment and again at the end of the pilot study. This data will then be analysed to assess the effectiveness of the Salaso app as a treatment option for AS.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Other: Physiotherapy Not Applicable

Detailed Description:

AS is a chronic inflammatory condition affecting the spine and other joints, causing pain and stiffness. Currently approximately 150 people attend Saint James's Hospital rheumatology department for management of their condition. Physiotherapy plays a key role in this management. As this is often a younger patient population, it can be challenging for them to attend appointments due to work and family commitments. It is envisaged that this pilot will enhance treatment options for all participants.

The aims of this study are: to improve use of exercise and physical activity using an online exercise application; to improve self-management skills in monitoring progress and ability to exercise independently using an online exercise application; to provide an online appointment review option to patients who are unable to attend physiotherapy appointments in St James's Hospital.

Descriptive statistics will be used to record and analyse the study data, using SPSS software.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the same intervention
Masking: None (Open Label)
Masking Description: No masking will take place
Primary Purpose: Treatment
Official Title: A Feasibility Study to Investigate the Use of Salaso to Increase Access to Physiotherapy and Increase Compliance to Exercise Prescription and Physical Activity in the Management of Ankylosing Spondylitis (AS).
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : April 17, 2019
Estimated Study Completion Date : May 31, 2019


Arm Intervention/treatment
Experimental: Physiotherapy via the Salaso Apllication Intervention

All participants' physiotherapy- prescribed exercise programmes will be monitored via the Salaso application. Telehealth appointments will occur monthly and modifications to exercises will be made as required.

This will continue for the 6-month duration of the intervention.

Other: Physiotherapy

Participants, with a confirmed diagnosis of AS, will be invited to participate. Once participants have provided informed consent, they will be required to complete the outcome measures provided. Participants will be set up to use the online exercise application and educated on its use.

Participants will then have access to videos of suitable exercises or exercise classes to follow and education material on their condition to read. Participants will be able to complete AS specific outcome measures and record their progress. Participants will also have a monthly video call with the senior rheumatology physiotherapist to discuss their exercise programme, symptoms and management. The participants will also record their compliance with their exercise programmes.

After the 6 month pilot period, participants will be required to complete the same outcome measures completed at the start of the study.

Other Name: Salaso




Primary Outcome Measures :
  1. Bath Ankylosing Spondylitis Metrology Index [ Time Frame: 6 months ]
    Measure of spinal mobility


Secondary Outcome Measures :
  1. Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: 6 months ]
    Measuring disease activity in AS

  2. Bath Ankylosing Spondylitis Functional Index [ Time Frame: 6 months ]
    Measuring functional activity in AS

  3. Arthritis Self-Efficacy Scale (ASES) [ Time Frame: 6 months ]
    The scale is an assessment of a person's ability to self-manage his/her pain, function and other symptoms. The self-efficacy function scale has 9 questions, each scored on a scale of 1-10, with a total minimum score of 10 and a maximum score of 90. The self-efficacy pain scale has 5 questions, with a total minimum score of 5 and a maximum score of 50. The self-efficacy other symptoms scale has 6 questions, with a minimum total score of 6 and a maximum score of 60. The other symptoms scale and the pain scale may be combined, with a sum score given.

  4. Exercise Benefits/Barriers Scale (EBBS) [ Time Frame: 6 months ]
    Measuring the perceived benefits of and barriers to performing the prescribed exercises. There are 43 questions in total. It may be scored in it's entirety or as two separate scales. Scores can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. The benefits scale is scored between 29 and 116. The barriers scale is scored between 14 and 56. The higher the score on the barriers scale, the greater the perception of barriers to exercise. If combined, the barriers scale is reverse-scored.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Ankylosing Spondylitis

Exclusion Criteria:

  • Previous spinal surgery
  • Spondylolisthesis
  • Unwillingness to participate
  • Unable to complete self-report questionnaires
  • Progressive neurological deficit
  • Neurological disease
  • Cauda equina syndrome
  • Unable to exercise on medical grounds

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): NCT03457285


Contacts
Contact: Ciaran Brennan 0035314162503 cbrennan2@stjames.ie
Contact: Mark McGowan 0035314162503 mmcgowan@tjames.ie

Locations
Ireland
Physiotherapy Department, Saint James's Hospital Recruiting
Dublin, Ireland
Contact: Ciarán Brennan, MSc, BSc         
Sponsors and Collaborators
St. James's Hospital, Ireland
Salaso Health Solutions Limited
Novartis
Investigators
Principal Investigator: Finbar O'Shea Consultant Rheumatologist, Saint James's Hospital

Responsible Party: Ciaran Brennan, Senior Physiotherapist in Rheumatologuy, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT03457285     History of Changes
Other Study ID Numbers: SJH AS Salaso Study
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ciaran Brennan, St. James's Hospital, Ireland:
Ankylosing spondylitis; physiotherapy; Salaso

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis