← Back to Search

Managing Fatigue:The Individual Program for Parkinson's Disease (MFIP Trial)

N/A
Waitlist Available
Research Sponsored by Dalhousie University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after six weeks at post test
Awards & highlights

MFIP Trial Summary

This pilot study aims to evaluate the feasibility of Managing Fatigue: The Individual Program (MFIP) in people living with Parkinson's disease. The Managing Fatigue Program, a six-week, self-management energy conservation course, focuses on strategies that help people with fatigue to make changes to save and use their energy to accomplish their daily activities. Several studies have adapted and evaluated different delivery formats of the program in conditions similar to Parkinson's disease, demonstrating that the Managing Fatigue Program is effective in reducing fatigue impact, depression, sleep problems, and improving quality of life, participation and self-efficacy. While this program has been tested in people living with many chronic conditions there has been only limited inclusion of people living with PD. This feasibility study, using a mixed-methods approach, nested in a pilot randomized control design, will evaluate the feasibility of the Individual Managing Fatigue Program from the perspectives of people with Parkinson's disease, and prepare for a full-scale randomized controlled trial (RCT). In this study, Managing Fatigue: The Individual Program (MFIP) will be delivered using videoconferencing. This feasibility study will use a mixed-methods approach, nested in a pilot two-armed randomized controlled design. Using a concurrent mixed-method design, we will collect two types of data (qualitative and quantitative) simultaneously, expanding our understanding of the feasibility of the program. Data will be collected using feasibility questionnaires developed by the research team, standard outcome measures, and group discussions. Multiple recruitment strategies will be used to recruit a convenience sample of 50 participants (25 in each group) from across the province of Nova Scotia, Canada. Eligible participants will be randomly assigned to either the control or experimental group using sealed envelopes. The study outcome measures will be administered three times during the study; pre-test, post-test after 6 weeks, and at three-month follow-up. The results of this study will determine whether it is feasible to do a full-scale RCT in the future. If the known beneficial effects of the Managing Fatigue program extend to the PD population, this research will be the evidence needed to support the integration of this novel solution into the care of people with PD.

Eligible Conditions
  • Parkinson's Disease

MFIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Canadian Occupational Performance Measure
Multidimensional Fatigue Inventory (MFI)
Occupational Balance Questionnaire
+3 more
Other outcome measures
Relevance, acceptability, and usability of each session of the Individual Managing Fatigue Program
Relevance, acceptability, and usability of the Individual Managing Fatigue Program
Socio-Demographic Questionnaire.

MFIP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Managing Fatigue:The Individual ProgramExperimental Treatment1 Intervention
Participants in the experimental group will receive the 6-week MFIP. Individuals in experimental group : will participate in six one-to-one sessions (each takes 60 to 90 minutes) will complete the Feasibility Questionnaire #1, after each session (10 questions) (Appendix 6) will complete Feasibility Questionnaire #2 after completing all six-sessions (12 questions) (Appendix 7) will complete the post-test measurement after completion of the program (approximately 60 minutes to complete) will complete the follow-up measurement, three months after the completion of the program (approximately 60 minutes to complete) will be advised to continue with their current healthcare services. may participate in one focus group (one-hour session)
Group II: Control GroupActive Control1 Intervention
Participants in the control group will not receive the IMFP and they will be advised to continue with their current healthcare services. Participants in the control group: will complete post-test measurements after 6 weeks (approximately 60 minutes), will complete the follow-up measurements three months later after completing the program (approximately 60 minutes). will be advised to continue with their current healthcare services. Following the study, participants in the control group will be offered the manual of the program and a three-hour training workshop after (three months after the baseline testing). In this workshop, they will learn about the about the program, including the pre-session activities, in-session activities, and homework. This workshop will be conducted by occupational therapists.

Find a Location

Who is running the clinical trial?

Dalhousie UniversityLead Sponsor
167 Previous Clinical Trials
403,115 Total Patients Enrolled
Tanya Packer, PhDStudy DirectorDalhousie University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Apr 2025