A Comparison of Accelerometers for Measuring Daily Activity in Sarcoid

December 7, 2015 updated by: University of East Anglia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR47UY
        • Norfolk and Norwich Univeristy Hospital NHS foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or Female aged over 18
  2. Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis.
  3. Ambulatory patient (not wheelchair or bed-bound)
  4. Able to provide written informed consent

Exclusion Criteria:

1. Unable to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sarcoidosis - GENEActiv device first
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.
Device: GENEActiv Original Accelerometer
Wrist-worn device measuring accelerations as a measure of daily activity.
Device: ActiGraph GT3X Accelerometer
Wrist-worn device measuring accelerations as a measure of daily activity.
Other: Sarcoidosis - ActiGraph device first
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.
Device: GENEActiv Original Accelerometer
Wrist-worn device measuring accelerations as a measure of daily activity.
Device: ActiGraph GT3X Accelerometer
Wrist-worn device measuring accelerations as a measure of daily activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 7 days of each device (day 7, day 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of activity measures (time in moderate or vigorous activity)
Time Frame: After 7 days of each device (day 7, day 14)
Comparison of time in moderate or vigorous activity between devices - is one device persistently recording lower levels of activity over the periods of activity?
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 recording minimum "valid" data (>10hrs day, 2 weekdays, 2 weekend days).
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)
Number of devices recording "full" data (>16hrs/day, 7 days)
After 7 days of each device (day 7, day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Investigators

  • Principal Investigator: Chris Atkins, MB/BS, University of East Anglia
  • Study Director: Andrew M Wilson, MD, University of East Anglia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.3-27.11.2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoidosis

Clinical Trials on GENEActiv Original Accelerometer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe