SarcoidosisNCT02626897
A Comparison of Accelerometers for Measuring Daily Activity in Sarcoid
A study testing GENEActiv Original Accelerometer and ActiGraph GT3X Accelerometer in people with Sarcoidosis, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This cross-over study of 12 patients with sarcoidosis will look at two different widely-used accelerometer devices. These devices are wrist worn and similar in size to a wrist-watch. They measure daily activity levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- GENEActiv Original Accelerometer and ActiGraph GT3X Accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to May 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged over 18
- Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis.
- Ambulatory patient (not wheelchair or bed-bound)
- Able to provide written informed consent
Who cannot join
- 1. Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich Univeristy Hospital NHS foundation Trust
Norwich, Norfolk, NR47UY
About this study
Official title: A Comparison of Two Wrist-worn Accelerometer Devices for the Measurement of Activity in Sarcoidosis Patients
This cross-over study of 12 patients with sarcoidosis will look at two different widely-used accelerometer devices. These devices are wrist worn and similar in size to a wrist-watch. They measure daily activity levels. The investigators hope to use one of these devices in the future within a randomised-controlled trial looking at using methylphenidate for the treatment of sarcoidosis-associated fatigue. In order to ensure that the investigators choose the ideal device the investigators wish to compare the GENEActiv and ActiGraph GT3X devices. Participants will be required to wear the devices for 7 days each, with 6 patients beginning with the GENEActiv device and changing to the ActiGraph device after 7 days, the remaining 6 participants starting with the Actigraph before changing to the GENEActiv. Patients will complete a short exit questionnaire about their experience with the devices and their preference. The best device will be determined by both patient preference and reliability of collecting data.
Read the detailed description
This will be a small comparator study comparing two devices (GENEActiv original and ActiGraph GT3X) in 12 patients with sarcoidosis. Participants wear one device for 7 days before returning the device, and wear the second device to wear for a further 7 day period. Each participant will wear the devices for 24 hours throughout the measurement period. The devices will be worn in a random order, randomised using sealed envelopes. They will be advised not to remove the devices during the 7 day monitoring period, with the exception of the GT3X which should be removed if the participant is bathing or swimming (they are able to shower). When each device is returned the participants will be asked to complete an exit questionnaire on their experience with the device. Before the participants wear the devices they will be asked to complete a short question regarding how tired/fatigued they feel.
The devices will be worn on the participant's non-dominant wrist. They will wear both devices in a random order (determined by randomisation at the start of the trial with regards to which device will be worn first). Six participants will start with the GENEActiv device and six will begin with the Actigraph GT3X device. The device order will be chosen randomly based upon a random number sequence generated in Microsoft Excel and placed in envelopes numbered 1 to 12.
- Conditions
- Sarcoidosis
- Being tested
- GENEActiv Original Accelerometer, ActiGraph GT3X Accelerometer
- Keywords
- Sarcoidosis, Daily activity, Exercise, Accelerometer
- Medical subject headings
- Sarcoidosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENEActiv Original AccelerometerDevice
Wrist-worn device measuring accelerations as a measure of daily activity.
ActiGraph GT3X AccelerometerDevice
Wrist-worn device measuring accelerations as a measure of daily activity.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis - GENEActiv device first | Other | Six patients start with the GENEActiv wrist-worn accelerometer which is needed to be worn for a 7 day period. Participants then switch to the ActiGraph GT3X device for a 7 day period. At the end of this second period they complete a short exit questionnaire detailing their experience and their device preference. Receives: Device: GENEActiv Original Accelerometer; Device: ActiGraph GT3X Accelerometer |
| Sarcoidosis - ActiGraph device first | Other | Six patients start with the ActiGraph GT3X wrist-worn accelerometer which is needed to be worn for a 7 day period. Participants then switch to the GENEActiv device for a 7 day period. At the end of this second period they complete a short exit questionnaire detailing their experience and their device preference. Receives: Device: GENEActiv Original Accelerometer; Device: ActiGraph GT3X Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient acceptability of devices
Visual analogue scale measures of patient acceptability of devices
Measured: After 7 days of each device (day 7, day 14)
Secondary outcomes (3)
Comparison of activity measures (time in moderate or vigorous activity)
Comparison of time in moderate or vigorous activity between devices - is one device persistently recording lower levels of activity over the periods of activity?
Measured: After 7 days of each device (day 7, day 14)
Number of devices with valid data
Number of devices recording minimum "valid" data (>10hrs day, 2 weekdays, 2 weekend days).
Measured: After 7 days of each device (day 7, day 14)
Number of devices with full data
Number of devices recording "full" data (>16hrs/day, 7 days)
Measured: After 7 days of each device (day 7, day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Atkins, MB/BS, Principal investigator, University of East AngliaAndrew M Wilson, MD, Study director, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626897
- Sponsor's protocol ID
- 1.3-27.11.2015
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Wrist-worn Accelerometer Devices for the Measurement of Activity in Sarcoidosis Patients
- ClinicalTrials.gov ID
- NCT02626897
- Acronym / sponsor ID
- 1.3-27.11.2015
- Conditions
- Sarcoidosis
- Keywords
- Sarcoidosis, Daily activity, Exercise, Accelerometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- 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 cross-over study of 12 patients with sarcoidosis will look at two different widely-used accelerometer devices. These devices are wrist worn and similar in size to a wrist-watch. They measure daily activity levels. The investigators hope to use one of these devices in the future within a randomised-controlled trial looking at using methylphenidate for the treatment of sarcoidosis-associated fatigue. In order to ensure that the investigators choose the ideal device the investigators wish to compare the GENEActiv and ActiGraph GT3X devices. Participants will be required to wear the devices for 7 days each, with 6 patients beginning with the GENEActiv device and changing to the ActiGraph device after 7 days, the remaining 6 participants starting with the Actigraph before changing to the GENEActiv. Patients will complete a short exit questionnaire about their experience with the devices and their preference. The best device will be determined by both patient preference and reliability of collecting data.
Detailed description
This will be a small comparator study comparing two devices (GENEActiv original and ActiGraph GT3X) in 12 patients with sarcoidosis. Participants wear one device for 7 days before returning the device, and wear the second device to wear for a further 7 day period. Each participant will wear the devices for 24 hours throughout the measurement period. The devices will be worn in a random order, randomised using sealed envelopes. They will be advised not to remove the devices during the 7 day monitoring period, with the exception of the GT3X which should be removed if the participant is bathing or swimming (they are able to shower). When each device is returned the participants will be asked to complete an exit questionnaire on their experience with the device. Before the participants wear the devices they will be asked to complete a short question regarding how tired/fatigued they feel.
The devices will be worn on the participant's non-dominant wrist. They will wear both devices in a random order (determined by randomisation at the start of the trial with regards to which device will be worn first). Six participants will start with the GENEActiv device and six will begin with the Actigraph GT3X device. The device order will be chosen randomly based upon a random number sequence generated in Microsoft Excel and placed in envelopes numbered 1 to 12.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis - GENEActiv device first | Other | Device: GENEActiv Original Accelerometer, Device: ActiGraph GT3X AccelerometerSix patients start with the GENEActiv wrist-worn accelerometer which is needed to be worn for a 7 day period. Participants then switch to the ActiGraph GT3X device for a 7 day period. At the end of this second period they complete a short exit questionnaire detailing their experience and their device preference. |
| Sarcoidosis - ActiGraph device first | Other | Device: GENEActiv Original Accelerometer, Device: ActiGraph GT3X AccelerometerSix patients start with the ActiGraph GT3X wrist-worn accelerometer which is needed to be worn for a 7 day period. Participants then switch to the GENEActiv device for a 7 day period. At the end of this second period they complete a short exit questionnaire detailing their experience and their device preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female aged over 18
- Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis.
- Ambulatory patient (not wheelchair or bed-bound)
- Able to provide written informed consent
Key exclusion criteria (1 listed)
- 1. Unable to provide informed consent.
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 |
|---|---|---|
| GENEActiv Original AccelerometerWrist-worn device measuring accelerations as a measure of daily activity. | Device | Sarcoidosis - ActiGraph device first, Sarcoidosis - GENEActiv device first |
| ActiGraph GT3X AccelerometerWrist-worn device measuring accelerations as a measure of daily activity. | Device | Sarcoidosis - ActiGraph device first, Sarcoidosis - GENEActiv device first |
Primary outcome
Patient acceptability of devices
Time frame: After 7 days of each device (day 7, day 14)
Visual analogue scale measures of patient acceptability of devices
3 secondary outcomes
Comparison of activity measures (time in moderate or vigorous activity)
Time frame: After 7 days of each device (day 7, day 14)
Number of devices with valid data
Time frame: After 7 days of each device (day 7, day 14)
Number of devices with full data
Time frame: After 7 days of each device (day 7, day 14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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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.
Chris Atkins, MB/BS principal investigator
University of East Anglia
Andrew M Wilson, MD study director
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENEActiv Original Accelerometer and ActiGraph GT3X Accelerometer in people with Sarcoidosis, run by University of East Anglia at 1 site in United Kingdom.
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 4 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chris Atkins, MB/BS (01603591594, c.atkins@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient acceptability of devices (time frame: After 7 days of each device (day 7, day 14)). 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 10 Dec 2015.