Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: the Use of a Mobile Application
Primary Purpose
Scoliosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scoliogold App
Pre-Formatted Diary
Sponsored by
About this trial
This is an interventional supportive care trial for Scoliosis
Eligibility Criteria
Inclusion Criteria:
- all patients who have completed an intensive course of treatment at Scoliosis SOS Clinic from 23.02.2018
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Group / Group 1
Group 2
Group 3
Arm Description
This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic.
This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic as well as a pre-formatted diary for them to fill out.
This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic as well as a link to download the free ScolioGold App on to their mobile from the clinic.
Outcomes
Primary Outcome Measures
The amount of hours per week exercised on average
Over the past 3 months, on average, how many hours per week do you spend on your scoliosis-specific exercises? is the question that will be asked.
Secondary Outcome Measures
Full Information
NCT ID
NCT03462264
First Posted
February 26, 2018
Last Updated
April 17, 2018
Sponsor
Scoliosis SOS Ltd.
Collaborators
Glynn Analytics
1. Study Identification
Unique Protocol Identification Number
NCT03462264
Brief Title
Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: the Use of a Mobile Application
Official Title
Stage 2: Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: Use of a Mobile Application
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2018 (Anticipated)
Primary Completion Date
December 21, 2018 (Anticipated)
Study Completion Date
December 21, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scoliosis SOS Ltd.
Collaborators
Glynn Analytics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a second study in a series of 3 studies. The first study assessed exercise compliance of scoliosis patients (adults and children). This study will look at different strategies to improve exercise compliance after a patient has completed an intensive course of treatment at Scoliosis SOS Clinic. It will be a randomised control trial. The control group will receive the regular exercise schedule that is created for the patients at the clinic, there will be two intervention groups, one using the exercise schedule with a diary and one using the exercise schedule with a mobile application. Compliance will be monitored through a questionnaire at their first and second check-up appointments which will take place every 3 months for a patient under the age of 18 and every 6 months for a patient who is 18 years old or over.
Detailed Description
Patients who have attended an intensive treatment course at Scoliosis SOS Clinic in London will be included in the study. This will include patients finishing an intensive course after the start date of the study or patients who have completed an intensive course up to 11 years ago and are still attending check-up appointments at the clinic. After a patient has completed this intensive course or when they come back for their next check-up appointment after the start date of the study, each patient will be randomised in to one of three groups: 1. Control group, 2. Diary group and 3. Mobile application group.
The patients in the control group will be given their normal exercise schedule without any instruction to record their compliance at the time. The diary group will be given a diary with a specific layout and instructed to note their exercise compliance, including the date, the amount of time and the exercises completed. The mobile application group will be provided with a link to download the application onto their smart phone for free. This group will be instructed to use this application whenever they complete their exercises at home.
The mobile application will include a copy of the patient's exercise schedule (they will also be provided with a hard copy of the exercise schedule), a picture list of all of the exercises present on their exercise schedule as well as a start/stop button which they will be advised to press once they begin their exercise and then again once they have finished exercising. This information will log on their profile, which can be accessed by the researcher.
The patients will be enrolled on to the study on the day that they finish their intensive physiotherapy course or at their next check-up appointment after the study commences. The patient will be given a full informed consent form, detailing every aspect of the study. They will then be asked to sign the form as their way of agreeing to take part in the study. Data will then be collected from each patient on the patient's first and second check-up appointments which usually occur once every three months for children below the age of 18 years old and once every six months for adults that are 18 years old and older. If the patient does not attend a check-up appointment within their recommended time period, they will be contacted via telephone or email to provide the details about their compliance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group / Group 1
Arm Type
No Intervention
Arm Description
This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic as well as a pre-formatted diary for them to fill out.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic as well as a link to download the free ScolioGold App on to their mobile from the clinic.
Intervention Type
Device
Intervention Name(s)
Scoliogold App
Intervention Description
The mobile application will include a list of the specific exercises that the patient has to complete on a daily basis. It will have a start/stop button which the patient presses at the beginning and the end of each time that they complete their home exercise programme. This will get logged on to their application which can be accessed by the researcher to monitor home exercise compliance.
Intervention Type
Other
Intervention Name(s)
Pre-Formatted Diary
Intervention Description
The pre-formatted diary will prompt the date, start time, end time and a list exercises that the patient has completed that day that the patient will be requested to fill out.
Primary Outcome Measure Information:
Title
The amount of hours per week exercised on average
Description
Over the past 3 months, on average, how many hours per week do you spend on your scoliosis-specific exercises? is the question that will be asked.
Time Frame
3 Months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients who have completed an intensive course of treatment at Scoliosis SOS Clinic from 23.02.2018
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgina C Frere, BSc
Phone
+442074884428
Email
therapist@scoliosissos.com
First Name & Middle Initial & Last Name or Official Title & Degree
David AJ Black, BSc
Phone
+442074884428
Email
jason.black@scoliosissos.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgina CA Frere, BSc
Organizational Affiliation
Scoliosis SOS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika Maude
Organizational Affiliation
Scoliosis SOS
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All of the data recorded will be anonymised and secured without the plan to share data to other researchers
Learn more about this trial
Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: the Use of a Mobile Application
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