NCT04508361

Brief Summary

This study aims to see if people's health related quality of life (how they feel about their health) changes over a 12 week period if they do not receive any change in their medicines. The investigators would like people to complete four questionnaires then repeat them after three months. The investigators need to do this to in order see what difference they should expect to detect if they give people treatment that works.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

July 10, 2020

Last Update Submit

August 10, 2020

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Fatigue Assessment Scale (FAS)

    Fatigue Assessment Scale (FAS) - ranges from 10 to 50 with higher values representing greater fatigue. There are a specified cut-off values for clinically significant fatigue (score \>= 22) and severe fatigue (score \>= 35).The questionaire was administered at baseline, 6 weeks and 12 weeks.

    Change from baseline to 12 weeks

Secondary Outcomes (4)

  • Short Form 36 (SF-36)

    Change from baseline to 12 weeks

  • Kings' Sarcoidosis Questionnaire (KSQ)

    Change from baseline to 12 weeks

  • Global rating of concept scale

    Change from baseline to 12 weeks

  • The global rating of change

    Change from 6 weeks to 12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with sarcoidosis and fatigue

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
  • Significant fatigue - defined as a FAS score of greater than 21 points
  • Has mental capacity to complete the questionnaires

You may not qualify if:

  • Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwich Medical School

Norwich, Norfolk, NR47TJ, United Kingdom

Location

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

August 11, 2020

Study Start

April 19, 2019

Primary Completion

May 10, 2020

Study Completion

November 1, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

GB(1)