ScoliosisNCT03462264
Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: the Use of a Mobile Application
A study testing Scoliogold App and Pre-Formatted Diary in people with Scoliosis, run by Scoliosis SOS Ltd..
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Scoliogold App and Pre-Formatted Diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients who have completed an intensive course of treatment at Scoliosis SOS Clinic from 23.02.2018
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stage 2: Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: Use of a Mobile Application
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.
Read the 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.
- Conditions
- Scoliosis
- Being tested
- Scoliogold App, Pre-Formatted Diary
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliogold AppDevice
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.
Pre-Formatted DiaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group / Group 1 | No intervention | This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic. |
| Group 2 | Experimental | 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. Receives: Other: Pre-Formatted Diary |
| Group 3 | Experimental | 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. Receives: Device: Scoliogold App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start24 Apr 2018 (estimated)
- Primary completion21 Dec 2018 (estimated)
- Study completion21 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scoliosis SOS Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glynn Analytics
- Responsible party
- Principal investigator, Georgina Frere, Scoliosis SOS Ltd.
- Investigators
- Georgina CA Frere, BSc, Principal investigator, Scoliosis SOSErika Maude, Study director, Scoliosis SOS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462264
- Sponsor's protocol ID
- Scoliosissos
- Status last verified
- Apr 2018
- First submitted
- 26 Feb 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All of the data recorded will be anonymised and secured without the plan to share data to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage 2: Strategies to Improve Home Exercise Compliance in Patients With Scoliosis: Use of a Mobile Application
- ClinicalTrials.gov ID
- NCT03462264
- Acronym / sponsor ID
- Scoliosissos
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Scoliosis SOS Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Glynn Analytics
- Study start
- 24 Apr 2018 (estimated)
- Primary completion
- 21 Dec 2018 (estimated)
- Study completion
- 21 Dec 2018 (estimated)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Control Group / Group 1 | No intervention | –This group will receive their personalised exercise schedule after treatment as per routine treatment at the clinic. |
| Group 2 | Experimental | Other: Pre-Formatted DiaryThis 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. |
| Group 3 | Experimental | Device: Scoliogold AppThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who have completed an intensive course of treatment at Scoliosis SOS Clinic from 23.02.2018
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scoliogold AppThe 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. | Device | Group 3 |
| Pre-Formatted DiaryThe 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. | Other | Group 2 |
Primary outcome
The amount of hours per week exercised on average
Time frame: 3 Months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: No. All of the data recorded will be anonymised and secured without the plan to share data to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgina CA Frere, BSc principal investigator
Scoliosis SOS
Erika Maude study director
Scoliosis SOS
Questions about this trial
What is this clinical trial studying?
A study testing Scoliogold App and Pre-Formatted Diary in people with Scoliosis, run by Scoliosis SOS Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgina C Frere, BSc (+442074884428, therapist@scoliosissos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of hours per week exercised on average (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.