Skip to main content
OpenTrials
Completed

NCT Number: NCT04401943

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline Modified Fatigue Impact Scale at 6 weeks

    Time frame: baseline, 6 weeks

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

  2. Change from baseline Multidimensional Assessment of Fatigue at 6 weeks

    Time frame: baseline, 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

Other outcomes

  1. Change from baseline Hospital Anxiety and Depression Scale at 6 weeks

    Time frame: baseline, 6 weeks

    Measures anxiety and depression

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

    Time frame: baseline, 6 weeks

    Measures participants' confidence in managing symptoms so as not to interfere with the activities they perform in day to day life.

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

    Time frame: baseline, 6 weeks

    Measures participants' confidence in their ability to use energy conservation strategies

  4. Energy Conservations Strategies Survey

    Time frame: 6 weeks

    Measures people's use of energy conservation strategies

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • University of California, San Diego

Registry information

Official study title

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

Acronym: FAME-ISS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 26, 2020
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.