Online Fatigue Intervention Program for People With Scleroderma (FAME-ISS)

Pilot Study of an Online Fatigue Intervention Program for People With Scleroderma

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: online fatigue intervention

Detailed Description

If eligible and give consent, participants will be asked to complete 2 online questionnaires. The first questionnaire asks basic information such as your age, gender, educational level, and amount of time diagnosed with systemic sclerosis. The second questionnaire asks about your disease symptoms.

You will also be asked to complete questionnaires about your fatigue, pain, mood, confidence in managing your disease and performing daily tasks, and knowledge and use of energy saving techniques.

Once you compete the questionnaires, you will be asked to compete a survey about times and days you would be available to attend the online videoconference fatigue program meeting over a 6 week period of time.

Once the time and dates for the fatigue program are scheduled, you will be expected to attend and take part (using visual and audio) in each 1 ½ hour meeting for 6 weeks online.

The fatigue program includes information on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise. Outside of meetings, you will also be expected to do any "homework" assignments in between the group meetings such as setting goals and doing activities to reach your goals.

At the end of the 6 weeks, you will be asked to complete the same questionnaires you did at the beginning of the study regarding, fatigue, pain, and ability to perform daily tasks. You will also be asked to complete an evaluation of the course.

3 months later, you will be asked to take part in a 45 minute telephone interview to talk about your fatigue and how you are using the ideas from the program.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Resident of the United States
• Diagnosis of systemic scleroderma
• 18 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fatigue intervention; the Fatigue intervention is a 6 week intervention delivered using video teleconferencing	Other: online fatigue intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Hospital Anxiety and Depression Scale at 6 weeks	Measures anxiety and depression	baseline, 6 weeks
Change from baseline PROMIS Self-Efficacy for Managing Symptoms at 6 weeks	Measures participants' confidence in managing symptoms so as not to interfere with the activities they perform in day to day life.	baseline, 6 weeks
Change from baseline Self-Efficacy for Performing Energy Conservation Strategies Assessment at 6 weeks	Measures participants' confidence in their ability to use energy conservation strategies	baseline, 6 weeks
Energy Conservations Strategies Survey	Measures people's use of energy conservation strategies	6 weeks

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Janet L Poole, PhD, University of New Mexico

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 19-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No