A Rehabilitation Therapy for Post-stroke Fatigue

NCT02131532 | Completed Phase 1 Results

• 1 other identifier: PSF-14/SS/0093
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of adult disability in the community. Fatigue affects about a third of stroke survivors. It results in difficulty taking part in everyday activities, and increases risk of hospitalization and death after stroke. Despite of its high prevalence and distressing consequences, there is no effective treatment. Psychological interventions have improved fatigue in patients with other conditions such as multiple sclerosis. These interventions primarily target patients' beliefs about overcoming fatigue and their physical activities in daily life. Also studies indicated that post-stroke fatigue is associated with mood. Based on this knowledge, the investigator has designed a brief psychological intervention for post-stroke fatigue. The current study is a feasibility study to test the adequacy of intervention manuals and the feasibility of trial processes. This study will need 12 stroke survivors who have post-stroke fatigue and are over three months but within two years after their stroke. Stroke survivors with severe depression or having insufficient capability in cognition or communication will not be included. The investigator will check their eligibility by questionnaires and interviews and then invite eligible people to take part in the study. This intervention will be delivered by a therapist (a clinical psychologist) to each participant through six face-to-face therapy sessions. Each session will be about one hour and be two weeks' apart. During the sessions, participants will discuss with the therapist their fatigue problems, and, with the support from the therapist, work out ways to solve their problems. One month after the last face-to-face session, each participant will receive a feedback session by telephone from the therapist. Each participant will be followed up to three months after the last face-to-face session. After all participants complete their feedback sessions, the investigator will invite them to a group meeting to share their experiences of taking part in this trial and makes suggestions as how their experiences of this intervention, and also of this trial, could be improved.

Conditions

Stroke

Keywords

Post-stroke fatigue; Psychological intervention; Feasibility

Outcome Measures

Primary Outcomes (4)

• Feasibility of Recruitment Process

  The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.

  3 months after the end of treatment

• Attendance of Treatment Sessions

  Number of participants who completed all treatment sessions.

  3 months after the end of treatment

• Feasibility of Telephone-delivered Booster Sessions

  Numbers of participants who attended the booster session as planned and those who rearranged the session

  3 months after the end of treatment

• Feasibility of Follow-up Assessment at Three Months After the End of Treatment

  Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.

  3 months after the end of treatment

Secondary Outcomes (12)

• Fatigue Assessment Scale (FAS)

  3 months after the end of treatment

• Patient Health Questionnaire-9 (PHQ-9)

  3 months after the end of treatment

• Nottingham Extended Activities of Daily Living (NEADL)

  3 months after the end of treatment

• Stroke Impact Scale (SIS) - General Rating of Recovery

  3 months after the end of treatment

• SIS - Physical Strength

  3 months after the end of treatment

Study Arms (1)

Psychological intervention

EXPERIMENTAL

This is a brief psychological intervention which targets patients' mood, their beliefs about their ability to overcome fatigue, and the scheduling of daily activities, with an aim to increase physical activities in daily life and finally reduce the level of fatigue. Each participant will meet a therapist in six face-to-face sessions. Each session will be about one hour and be two weeks apart. During the sessions, the participant will discuss with the therapist their problems related to fatigue and work through an intervention manual to learn skills to overcome these problems.

Behavioral: A brief psychological intervention

Interventions

A brief psychological intervention BEHAVIORAL

This intervention is based on the principle of cognitive-behavioral therapy

Psychological intervention

Eligibility Criteria

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

You may qualify if:

• Had a clinical diagnosis of stroke in the past three to 24 months (including minor stroke)
• Have post-stroke fatigue
• Over 18 years old
• Live in the Lothian area, Scotland

You may not qualify if:

• Have severe depression (with a total score of the Patient Health Questionnaire-9 of 15 or more)
• Have severe cognitive deficits
• Have severe aphasia
• Have significant difficulty in verbal communication
• Medically unstable or have another unfavorable condition that could impact results (e.g. substance abuse)
• Being in the nursing home
• Currently in another research study that might affect fatigue or add significant burden to participants, e.g. studies have outcome measures for fatigue or involve physical training

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (4)

• Wu S, Barugh A, Macleod M, Mead G. Psychological associations of poststroke fatigue: a systematic review and meta-analysis. Stroke. 2014 Jun;45(6):1778-83. doi: 10.1161/STROKEAHA.113.004584. Epub 2014 Apr 29.

  PMID: 24781083 BACKGROUND

• Duncan F, Wu S, Mead GE. Frequency and natural history of fatigue after stroke: a systematic review of longitudinal studies. J Psychosom Res. 2012 Jul;73(1):18-27. doi: 10.1016/j.jpsychores.2012.04.001. Epub 2012 Apr 29.

  PMID: 22691555 BACKGROUND

• Wu S, Mead G, Macleod M, Chalder T. Model of understanding fatigue after stroke. Stroke. 2015 Mar;46(3):893-8. doi: 10.1161/STROKEAHA.114.006647. Epub 2015 Feb 3. No abstract available.

  PMID: 25649798 BACKGROUND

• Wu S, Chalder T, Anderson KE, Gillespie D, Macleod MR, Mead GE. Development of a psychological intervention for fatigue after stroke. PLoS One. 2017 Aug 17;12(8):e0183286. doi: 10.1371/journal.pone.0183286. eCollection 2017.

  PMID: 28817725 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The aim of this single-arm pilot study was to test the feasibility of the intervention programme. This study can not inform the sample size calculation or efficacy of the intervention, which should be investigated in randomised controlled trials.

Results Point of Contact

• Title: Dr Simiao Wu
• Organization: University of Edinburgh

simiao.wu@ed.ac.uk

0044-131-242-6371

Study Officials

• Simiao Wu, MD, PhD

  Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 6, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 20, 2017
• Results First Posted: August 7, 2015

Record last verified: 2015-07

Locations

GB (1)