A Rehabilitation Therapy for Post-stroke Fatigue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02131532
First received: April 28, 2014
Last updated: July 31, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: A brief psychological intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of a Brief Psychological Intervention for Post-stroke Fatigue

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Feasibility of Recruitment Process [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.

  • Attendance of Treatment Sessions [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    Number of participants who completed all treatment sessions.

  • Feasibility of Telephone-delivered Booster Sessions [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    Numbers of participants who attended the booster session as planned and those who rearranged the session

  • Feasibility of Follow-up Assessment at Three Months After the End of Treatment [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.


Secondary Outcome Measures:
  • Fatigue Assessment Scale (FAS) [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]

    This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study).

    The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity.


  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.

  • Nottingham Extended Activities of Daily Living (NEADL) [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.

  • Stroke Impact Scale (SIS) - General Rating of Recovery [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.

  • SIS - Physical Strength [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Memory and Thinking [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Emotion [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Communication [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Daily Activities [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Mobility [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Hand Function [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.

  • SIS - Social Activity [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
    The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.


Enrollment: 12
Study Start Date: July 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological intervention

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131532

Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: Simiao Wu, MD, MSc Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom
  More Information

Publications:
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02131532     History of Changes
Other Study ID Numbers: PSF-14/SS/0093
Study First Received: April 28, 2014
Results First Received: May 27, 2015
Last Updated: July 31, 2015
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Post-stroke fatigue
Psychological intervention
Feasibility

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 03, 2015