A Rehabilitation Therapy for Post-stroke Fatigue

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Edinburgh
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02131532
First received: April 28, 2014
Last updated: May 2, 2014
Last verified: April 2014
  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 each of the three recruitment approaches [ Time Frame: 1 week after the completion of recruitment ] [ Designated as safety issue: No ]
    We will analyse if the three proposed recruitment approaches would work, i.e. from the stroke ward, from the stroke clinic, and from community. We will compare the number of potential participants that we can initially approach through each of these approaches, and the final number of participants recruited from each approach.

  • Feasibility of the measures of clinical outcomes [ Time Frame: 1 week after the completion of recruitment ] [ Designated as safety issue: No ]
    Number of missing items of each questionnaire (at baseline assessment) and reasons for not completing certain item(s)

  • Feasibility of the process of therapy delivery [ Time Frame: 1 month after the last face-to-face therapy session ] [ Designated as safety issue: No ]
    Number of participants completing all therapy sessions and reasons for withdrawal

  • Acceptability of the intervention [ Time Frame: 1 month after the last face-to-face therapy session ] [ Designated as safety issue: No ]
    Both the therapist and all participants will complete a feedback form and attend a feedback meeting to share their experiences of taking part in this trial.

  • Feedback on adapting this intervention for the nurse-led delivery [ Time Frame: 1 month after the last face-to-face therapy session ] [ Designated as safety issue: No ]

    After all participants complete their feedback sessions with the therapist, the investigator will invite all participants to a group meeting. At this meeting, they will be invited to give suggestions as how they think this intervention could be adapted to be delivered by stroke nurses.

    Also the Chief Investigator will have a feedback meeting with the therapist to discuss adapting this intervention to be delivered by stroke nurses.


  • Feasibility of three-month follow up [ Time Frame: 1 week after the completion of three-month follow up for all participants ] [ Designated as safety issue: No ]
    Number of participants returning questionnaires and reasons for not returning


Secondary Outcome Measures:
  • Fatigue [ Time Frame: Baseline, immediately after treatment, 1 month after treatment, and 3 months after treatment ] [ Designated as safety issue: No ]
    Fatigue is the primary clinical outcome for this intervention. It will be assessed by the Fatigue Assessment Scale and a case definition of post-stroke fatigue.

  • Depression [ Time Frame: Baseline, immediately after treatment, 1 month after treatment, and 3 months after treatment ] [ Designated as safety issue: No ]
    Depression will be assessed by the Patient Health Questionnaire-9

  • Dependency in daily life [ Time Frame: Baseline, immediately after treatment, 1 month after treatment, and 3 months after treatment ] [ Designated as safety issue: No ]
    Dependency in daily life will be assessed by the Nottingham Extended Activities of Daily Living

  • Stroke-specific health-related quality of life [ Time Frame: Baseline, immediately after treatment, 1 month after treatment, and 3 months after treatment ] [ Designated as safety issue: No ]
    Stroke-specific health-related quality of life will be assessed by the Stroke Impact Scale version 3.0


Estimated Enrollment: 12
Study Start Date: June 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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

Contacts
Contact: Simiao Wu, MD, MSc 0044-131-242-6371 simiao.wu@ed.ac.uk
Contact: Gillian E Mead, MD, FRCP 0044-131-242-6481 gillian.e.mead@ed.ac.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Not yet recruiting
Edinburgh, Scotland, United Kingdom, EH16 4SA
Contact: Simiao Wu, MD, MSc    0044-131-242-6371    simiao.wu@ed.ac.uk   
Contact: Gillian E Mead, MD, FRCP    0044-131-242-6481    gillian.e.mead@ed.ac.uk   
Principal Investigator: Simiao Wu, MD, MSc         
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
Last Updated: May 2, 2014
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:
Fatigue
Stroke
Cerebral Infarction
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014