Protocol of the Packer Managing Fatigue Program Versus Standard Information to Improve Energy Conservation Self-Efficacy in Parkinson's Disease

NCT07094269 | Recruiting DMC

• 1 other identifier: USGenova
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes a randomized, controlled, parallel-group, trial evaluating the effectiveness of a group-based fatigue management program for people with Parkinson's disease. The study will be conducted in Italy, with participant recruitment planned to begin on July 1st, 2025. The primary sponsor is the Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) at the University of Genoa, Italy. No external sources of monetary or material support have been declared. The study has received ethical approval from the University of Genoa's Research Ethics Committee (Comitato Etico per la Ricerca di Ateneo - CERA), under protocol number 2025.36, approved on April 3rd, 2025. The scientific title of the trial is: Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease". The public title is: "Energy Matters: A Protocol of a Randomized Controlled Trial of a Group-Based Fatigue Management Program for People with Parkinson's Disease". The study targets individuals diagnosed with idiopathic Parkinson's disease, experiencing fatigue. Eligible participants must be over 18 years old, present with Hoehn and Yahr stage ≤3.5, and score ≥4 on the Fatigue Severity Scale (FSS). Exclusion criteria include a Montreal Cognitive Assessment (MOCA) score below 21, presence of severe psychiatric comorbidities, medical conditions contributing independently to fatigue, inability to participate in group sessions, or involvement in other structured fatigue management programs. Participants will be randomly allocated to one of two arms. The intervention group will attend a six-week Packer Managing Fatigue Program1 Sessions will be conducted in groups of 8-10 participants, led by a licensed occupational therapist. Topics covered include rest, communication, body mechanics, ergonomics, energy-conserving tools, prioritization, lifestyle balance, and goal setting. Sessions will use standardized materials such as participant workbooks2 and visual aids and will take place in appropriately equipped rooms. If a participant is absent from a scheduled group session for personal reasons, the occupational therapist will organize an individual make-up session before the next scheduled group session. This individual session will follow the same content and structure as the missed group session, based on the Packer Managing Fatigue Program. Its purpose is to ensure continuity and fidelity to the intervention, and to allow participants to stay aligned with the group program. Participants in the control group will be provided with six fact sheets addressing general information about Parkinson's disease. The primary outcome is the change in self-efficacy for performing energy conservation strategies, measured using the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA), assessed at baseline, post-intervention, and at a 3-month follow-up. Secondary outcomes include measures of motor and non-motor symptoms (Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II), fatigue severity (Fatigue Severity Scale, Parkinson Fatigue Scale), Fatigue Impact (Modified Fatigue Impact Scale), quality of life (Parkinson Disease Questionnaire-39), participation and autonomy (Impact on Participation and Autonomy questionnaire), psychiatric symptoms (Hospital Anxiety and Depression Scale), and sleep disturbance (Pittsburgh Sleep Quality Index - PSQI). All outcomes will be reassessed immediately and 3 months after the end of the intervention. The total planned sample size is 74 participants, with 37 individuals in each study arm. For public queries, the contact person is Dr. Elisa Pelosin, Associate Professor at DINOGMI, University of Genoa (email: elisa.pelosin@unige.it). For scientific queries, the reference contact is the University of Genoa's Ethics Committee (email: presidente.cera@unige.it). An individual participant data sharing plan is in place. As part of the informed consent process, participants will be asked whether they agree to allow their anonymized data to be shared for future research purposes. Only data from participants who provide explicit consent will be shared. Anonymized individual data will be made available upon reasonable request, in accordance with institutional policies and data protection regulations. Access will be granted by the corresponding author after publication and will remain open for five years

Conditions

PARKINSON DISEASE (Disorder)

Keywords

occupational therapy; fatigue; parkinson's disease; self-management

Outcome Measures

Primary Outcomes (1)

• Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)

  The SEPECSA was originally developed by Liepold and Mathiowetz's (2005) confidence in applying energy conservation strategies among individuals with MS. It consists of 14 items listing energy-saving strategies, with each item scored on a 10-point Likert-type scale (1 = "I never do it," 10 = "I always do it"). The assessment took approximately 10-15 minutes to complete. The final score was found by adding the total items' score and dividing it by 14. Psychometric properties of the original SEPECSA include high internal consistency (Cronbach's alpha = 0.93) and acceptable construct validity, as demonstrated by its correlation with fatigue levels and quality-of-life measures. This instrument measures individuals' confidence in implementing specific fatigue management techniques in daily life.

  Baseline, End of Treatment (7 week) and at 3 months

Secondary Outcomes (9)

• Fatigue Severity Scale (FSS)

  Baseline, End of Treatment (7 week) and at 3 months

• Parkinson Fatigue Scale (PFS)

  Baselibe, End of Treatment /7 weeks) and 3 months

• Modified Fatigue Impact Scale (MFIS)

  Baseline, End of Treatment /7 weeks), 3 months

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  Baseline, End of Treatment (7 weeks), at 3 months

• Impact on Participation and Autonomy (IPA)

  Baseline, end of treatment /7 weeks), at 3 months

Study Arms (2)

Packer Managing Fatigue Program

EXPERIMENTAL

Packer Managing Fatigue Group Program, delivered in groups of 8-10 by a licensed occupational therapist. The intervention will consist of six weekly sessions, each lasting 120 minutes, held in a dedicated outpatient room equipped with a whiteboard, group seating, and educational materials. Each session will address a specific theme: (1) The importance of Rest, (2) Communication and Body Mechanics, (3) Tools, Technology, and ergonomics, (4) Priorities and Standard (5) Putting it all Together, (6) Some Closing Thoughts. Materials will include a participant workbook2, printed handouts, pens, markers, and name tags. All materials will be provided in Italian. A structured intervention manual and session-specific checklists will guide therapist and ensure intervention fidelity.

Other: Occupational Therapy Intervention

Fact sheets about Parkinson's disease

PLACEBO COMPARATOR

Participants in the control group will be provided with six fact sheets (one per week) addressing general information about Parkinson's disease,. The control group reflects current standard care, as no structured fatigue intervention is routinely provided in this clinical setting.

Behavioral: Fact-sheets

Interventions

Occupational Therapy Intervention OTHER

Participants in the intervention group will take part in the structured, manualized Packer Managing Fatigue Group Program (Packer et al.), delivered in groups of 8-10 by a licensed occupational therapist. The intervention will consist of six weekly sessions, each lasting 120 minutes, held in a dedicated outpatient room equipped with a whiteboard, group seating, and educational materials. Each session will address a specific theme: (1) The importance of Rest, (2) Communication and Body Mechanics, (3) Tools, Technology, and ergonomics, (4) Priorities and Standard (5) Putting it all Together, (6) Some Closing Thoughts. Materials will include a participant workbook2, printed handouts, pens, markers, and name tags. All materials will be provided in Italian.

Packer Managing Fatigue Program

Fact-sheets BEHAVIORAL

Participants in the control group will receive six weekly fact sheets containing general information about Parkinson's disease. These fact sheets serve as a placebo intervention to control for attention and information exposure, without providing any structured fatigue management strategies. This approach helps isolate the specific effects of the active intervention compared to usual care.

Fact sheets about Parkinson's disease

Eligibility Criteria

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

You may qualify if:

• aged \>18 years
• diagnosis of idiopathic Parkinson's disease (PD)
• Hoehn and Yahr stage ≤3.5
• Fatigue Severity Scale (FSS) \>= 4

You may not qualify if:

• Montreal Cognitive Assessment (MoCA) score \<22
• comorbid medical conditions that could independently contribute to fatigue
• not being fluent in the Italian language
• Parkinsonism

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

Study Sites (1)

Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) University of Genoa Genoa, Italy

Genova, Italy

RECRUITING

Related Publications (13)

• Antonini A, Abbruzzese G, Ferini-Strambi L, Tilley B, Huang J, Stebbins GT, Goetz CG, Barone P; MDS-UPDRS Italian Validation Study Group; Bandettini di Poggio M, Fabbrini G, Di Stasio F, Tinazzi M, Bovi T, Ramat S, Meoni S, Pezzoli G, Canesi M, Martinelli P, Maria Scaglione CL, Rossi A, Tambasco N, Santangelo G, Picillo M, Morgante L, Morgante F, Quatrale R, Sensi M, Pilleri M, Biundo R, Nordera G, Caria A, Pacchetti C, Zangaglia R, Lopiano L, Zibetti M, Zappia M, Nicoletti A, Quattrone A, Salsone M, Cossu G, Murgia D, Albanese A, Del Sorbo F. Validation of the Italian version of the Movement Disorder Society--Unified Parkinson's Disease Rating Scale. Neurol Sci. 2013 May;34(5):683-7. doi: 10.1007/s10072-012-1112-z. Epub 2012 Jun 8.

  PMID: 22678179 BACKGROUND

• Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.

  PMID: 22526760 BACKGROUND

• Franchignoni F, Ferriero G, Giordano A, Guglielmi V, Picco D. Rasch psychometric validation of the Impact on Participation and Autonomy questionnaire in people with Parkinson's disease. Eura Medicophys. 2007 Dec;43(4):451-61.

  PMID: 18084167 BACKGROUND

• Pietrodarchi A, Berardi A, Galeoto G, Panuccio F, Simeon R. Validation of IPA and SEPECSA in Italian Individuals With Multiple Sclerosis: A Psychometric Study. OTJR (Thorofare N J). 2025 May 12:15394492251331445. doi: 10.1177/15394492251331445. Online ahead of print.

  PMID: 40353487 BACKGROUND

• Galeoto G, Colalelli F, Massai P, Berardi A, Tofani M, Pierantozzi M, Servadio A, Fabbrini A, Fabbrini G. Quality of life in Parkinson's disease: Italian validation of the Parkinson's Disease Questionnaire (PDQ-39-IT). Neurol Sci. 2018 Nov;39(11):1903-1909. doi: 10.1007/s10072-018-3524-x. Epub 2018 Aug 7.

  PMID: 30088166 BACKGROUND

• Finlayson M, Preissner K, Cho C. Outcome moderators of a fatigue management program for people with multiple sclerosis. Am J Occup Ther. 2012 Mar-Apr;66(2):187-97. doi: 10.5014/ajot.2012.003160.

  PMID: 22394528 BACKGROUND

• Akbar N, Turpin K, Petrin J, Smyth P, Finlayson M. A pilot mixed-methods evaluation of MS INFoRm: a self-directed fatigue management resource for individuals with multiple sclerosis. Int J Rehabil Res. 2018 Jun;41(2):114-121. doi: 10.1097/MRR.0000000000000271.

  PMID: 29324506 BACKGROUND

• Hersche R, Weise A, Michel G, Kesselring J, Bella SD, Barbero M, Kool J. Three-week inpatient energy management education (IEME) for persons with multiple sclerosis-related fatigue: Feasibility of a randomized clinical trial. Mult Scler Relat Disord. 2019 Oct;35:26-33. doi: 10.1016/j.msard.2019.06.034. Epub 2019 Jun 29.

  PMID: 31280074 BACKGROUND

• Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, Preston J, Walker A, Williamson P, Young B. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open. 2014 Jul 23;4(7):e005234. doi: 10.1136/bmjopen-2014-005234.

  PMID: 25056972 BACKGROUND

• Thomas S, Thomas PW, Kersten P, Jones R, Green C, Nock A, Slingsby V, Smith AD, Baker R, Galvin KT, Hillier C. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1092-9. doi: 10.1136/jnnp-2012-303816. Epub 2013 May 21.

  PMID: 23695501 BACKGROUND

• Alizadeh N, Packer TL, Sturkenboom I, Eskes G, Warner G. Managing Fatigue in Parkinson's Disease: Protocol for a Pilot Randomized Controlled Trial. Can J Occup Ther. 2022 Jun;89(2):180-189. doi: 10.1177/00084174221085449. Epub 2022 Mar 15.

  PMID: 35287487 BACKGROUND

• Packer, T.L., Lehman, M.J., Brink, N., & Sauriol, A. (2022). Packer Managing Fatigue: A Six-Week Self-Management Group Program (2nd ed., Participant Manual). Think Self-Management Inc. https://www.thinkselfmanagement.ca. ISBN: 978-1-7387441-0-7

  BACKGROUND

• Packer, T.L., Lehman, M.J., Brink, N., & Sauriol, A. (2022). Packer Managing Fatigue: A Six-Week Self-Management Group Program (2nd ed., Therapist Manual). Think Self-Management Inc. https://www.thinkselfmanagement.ca. ISBN: 978-1-7387441-0-7

  BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elisa Pelosin

CONTACT

+393482609897; elisa.pelosin@unige.it

Rachele Simeon

CONTACT

+393472231175; rachele.simeon@edu.unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, neither participants nor care providers will be masked to treatment allocation. However, data analysts and outcome assessors responsible for evaluating clinician-reported outcomes will be masked to group assignment to reduce the risk of assessment bias. To ensure assessor blinding, the individuals performing clinical outcome evaluations were not involved in participant enrollment or intervention delivery and were not informed of the assigned treatment groups. Participants and staff were instructed not to disclose allocation information during assessments. No blinding procedures were applied to the appearance or labeling of interventions, as blinding was not feasible for other roles
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This will be a two-arm controlled trial adopting a superiority framework. Participants will be allocated to either the intervention group or the control group using a stratified block allocation approach with a 1:1 ratio.

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)