Online Fatigue Intervention Program for People With Scleroderma

NCT04401943 | Completed

• 1 other identifier: 19-083
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to evaluate if an online fatigue intervention program will decrease fatigue, pain and increase confidence managing fatigue and being able to do daily tasks. This study involves competing a series of questionnaires before and after the intervention , and attending and participating in the online videoconference fatigue program for 1 1/2 hour meetings each week over a 6-week period of time.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Change from baseline Modified Fatigue Impact Scale at 6 weeks

  self report of impact of fatigue on physical, cognitive and psychosocial functioning

  baseline, 6 weeks

• Change from baseline Multidimensional Assessment of Fatigue at 6 weeks

  Measures four subjective domains of fatigue: degree and severity, amount of distress it causes, timing, and degree to which fatigue interferes with the activities of daily living

  baseline, 6 weeks

Other Outcomes (4)

• Change from baseline Hospital Anxiety and Depression Scale at 6 weeks

  baseline, 6 weeks

• Change from baseline PROMIS Self-Efficacy for Managing Symptoms at 6 weeks

  baseline, 6 weeks

• Change from baseline Self-Efficacy for Performing Energy Conservation Strategies Assessment at 6 weeks

  baseline, 6 weeks

Study Arms (1)

Fatigue intervention

EXPERIMENTAL

the Fatigue intervention is a 6 week intervention delivered using video teleconferencing

Other: online fatigue intervention

Interventions

online fatigue intervention OTHER

on line teleconferencing fatigue intervention for 6 weeks on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise.

Fatigue intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of the United States
• Diagnosis of systemic scleroderma
• years of age or older
• Have use of a device with internet and email access, and video conferencing capabilities (both audio and visual)
• Communicate in English
• Have fatigue (combined score of \>12 on 3 questions that rate degree of fatigue, severity of fatigue, and level of stress caused by fatigue on a scale from 1 - 10)
• Be willing and available to complete the study protocol which consists of attending a 1.5 hour virtual meeting once a week for 6 weeks.

You may not qualify if:

• Pregnancy
• Not having use of a device with internet, email access, and video conferencing capabilities (both audio and visual)
• Not able to communicate in English
• Score \< 12 on the fatigue screening questions
• Not willing or not able to complete the study protocol or participate in the program at the designated times and days.

Sponsors & Collaborators

• University of New Mexico: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Publications (1)

• Carandang K, Poole J, Connolly D. Fatigue and activity management education for individuals with systemic sclerosis: Adaptation and feasibility study of an intervention for a rare disease. Musculoskeletal Care. 2022 Sep;20(3):593-604. doi: 10.1002/msc.1617. Epub 2022 Feb 6.

  PMID: 35124888 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Janet L Poole, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 26, 2020
• Study Start: May 13, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)