Phase 2
N=12
A Rehabilitation Therapy for Post-stroke Fatigue
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02131532 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Feasibility of Recruitment Process — 120; 49; 20; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- A brief psychological intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Edinburgh
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment Process |
120; 49; 20; 12 | — |
| PRIMARY Attendance of Treatment Sessions |
8 | — |
| PRIMARY Feasibility of Telephone-delivered Booster Sessions |
1; 7 | — |
| PRIMARY Feasibility of Follow-up Assessment at Three Months After the End of Treatment |
6; 2 | — |
| SECONDARY Fatigue Assessment Scale (FAS) |
17.25 | 0.03 sig |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
5.00 | 0.10 |
| SECONDARY Nottingham Extended Activities of Daily Living (NEADL) |
21.00 | 0.45 |
| SECONDARY Stroke Impact Scale (SIS) - General Rating of Recovery |
88.63 | 0.03 sig |
| SECONDARY SIS - Physical Strength |
89.84 | 0.89 |
| SECONDARY SIS - Memory and Thinking |
87.05 | 0.009 sig |
| SECONDARY SIS - Emotion |
84.38 | 0.009 sig |
| SECONDARY SIS - Communication |
87.50 | 0.10 |
| SECONDARY SIS - Daily Activities |
95.94 | 0.09 |
| SECONDARY SIS - Mobility |
91.32 | 0.03 sig |
| SECONDARY SIS - Hand Function |
95.63 | 0.58 |
| SECONDARY SIS - Social Activity |
82.42 | 0.006 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02131532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.