Online Fatigue Intervention Program for People With Scleroderma

Systemic Sclerosis Clinical Trial

— FAME-ISS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04401943
• Other study ID #: 19-083
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Hospital Anxiety and Depression Scale at 6 weeks	Measures anxiety and depression	baseline, 6 weeks
Other	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
Other	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
Other	Energy Conservations Strategies Survey	Measures people's use of energy conservation strategies	6 weeks
Primary	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
Primary	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