Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03457285|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Other: Physiotherapy||Not Applicable|
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|
|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|
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.
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
- Bath Ankylosing Spondylitis Metrology Index [ Time Frame: 6 months ]Measure of spinal mobility
- Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: 6 months ]Measuring disease activity in AS
- Bath Ankylosing Spondylitis Functional Index [ Time Frame: 6 months ]Measuring functional activity in AS
- 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.
- 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.
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
|Contact: Ciaran Brennanfirstname.lastname@example.org|
|Contact: Mark McGowanemail@example.com|
|Physiotherapy Department, Saint James's Hospital||Recruiting|
|Contact: Ciarán Brennan, MSc, BSc|
|Principal Investigator:||Finbar O'Shea||Consultant Rheumatologist, Saint James's Hospital|