NCT02626897

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

December 2, 2015

Last Update Submit

December 7, 2015

Conditions

Sarcoidosis

Keywords

SarcoidosisDaily activityExerciseAccelerometer

Outcome Measures

Primary Outcomes (1)

  • Patient acceptability of devices

    Visual analogue scale measures of patient acceptability of devices

    After 7 days of each device (day 7, day 14)

Secondary Outcomes (3)

  • Comparison of activity measures (time in moderate or vigorous activity)

    After 7 days of each device (day 7, day 14)

  • Number of devices with valid data

    After 7 days of each device (day 7, day 14)

  • Number of devices with full data

    After 7 days of each device (day 7, day 14)

Study Arms (2)

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.

Device: GENEActiv Original AccelerometerDevice: 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.

Device: GENEActiv Original AccelerometerDevice: ActiGraph GT3X Accelerometer

Interventions

GENEActiv Original AccelerometerDEVICE

Wrist-worn device measuring accelerations as a measure of daily activity.

Sarcoidosis - ActiGraph device firstSarcoidosis - GENEActiv device first
ActiGraph GT3X AccelerometerDEVICE

Wrist-worn device measuring accelerations as a measure of daily activity.

Sarcoidosis - ActiGraph device firstSarcoidosis - GENEActiv device first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich Univeristy Hospital NHS foundation Trust

Norwich, Norfolk, NR47UY, United Kingdom

Location

MeSH Terms

Conditions

SarcoidosisMotor Activity

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesBehavior

Study Officials

  • Chris Atkins, MB/BS

    University of East Anglia

    PRINCIPAL INVESTIGATOR

  • Andrew M Wilson, MD

    University of East Anglia

    STUDY DIRECTOR

Central Study Contacts

Chris Atkins, MB/BS

CONTACT

01603591594c.atkins@uea.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 10, 2015

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

GB(1)