Stroke Clinical Trial
Official title:
A Feasibility Study of a Brief Psychological Intervention for Post-stroke Fatigue
Verified date | July 2015 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Attendance of Treatment Sessions | Number of participants who completed all treatment sessions. | 3 months after the end of treatment | |
Primary | 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 | |
Primary | 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 | Fatigue Assessment Scale (FAS) | 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. |
3 months after the end of treatment | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms. | 3 months after the end of treatment | |
Secondary | Nottingham Extended Activities of Daily Living (NEADL) | The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence. | 3 months after the end of treatment | |
Secondary | Stroke Impact Scale (SIS) - General Rating of Recovery | 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. | 3 months after the end of treatment | |
Secondary | SIS - Physical Strength | 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. | 3 months after the end of treatment | |
Secondary | SIS - Memory and Thinking | 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. | 3 months after the end of treatment | |
Secondary | SIS - Emotion | 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. | 3 months after the end of treatment | |
Secondary | SIS - Communication | 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. | 3 months after the end of treatment | |
Secondary | SIS - Daily Activities | 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. | 3 months after the end of treatment | |
Secondary | SIS - Mobility | 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. | 3 months after the end of treatment | |
Secondary | SIS - Hand Function | 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. | 3 months after the end of treatment | |
Secondary | SIS - Social Activity | 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. | 3 months after the end of treatment |
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