search
Back to results

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
Scoliosis SOS Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Scoliosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 26, 2018
    Last Updated
    April 17, 2018
    Sponsor
    Scoliosis SOS Ltd.
    Collaborators
    Glynn Analytics
    search

    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

    We'll reach out to this number within 24 hrs