Post-stroke FatiguePOSITIFNCT03551327
POst Stroke Intervention Trial In Fatigue (POSITIF)
A study testing Experimental: Intervention plus information and Active Comparator: Information only in people with Post-stroke Fatigue, run by University of Edinburgh at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to assess whether a brief cognitive behavioural intervention for post-stroke fatigue leads to clinically relevant improvements in fatigue after 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Fatigue
- What is being tested?
- Experimental: Intervention plus information and Active Comparator: Information only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 19 Nov 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Stroke 3 months to 2 years previously. Both ischaemic and haemorrhagic, including subarachnoid haemorrhage
- Capacity to consent
- Not living in nursing home.
- Medically stable,
- Answers 'Yes' to both the following questions about fatigue
- 'Do you feel tired all the time or get tired very quickly since your stroke'?
- Would you like additional help and support for this?
Who cannot join
- Unlikely to be available for follow-up for the next 6 months e.g. no fixed home address
- Other life-threatening illness (e.g. advanced cancer or advanced heart failure) that will make survival for 6 months unlikely
- Aphasia or cognitive impairment which is severe enough to prevent participation in the intervention. To assess this, patients will self-report their language and cognition from the relevant domains in the Short Stroke Impact Scale ('In the past week, how difficult was it for you to think quickly?' and 'In the past week, how difficult was it to understand what was being said to you in a conversation?') Those who respond 'very difficult' or 'could not do at all' to either question will be excluded. (24). Those who might be in these categories are likely to be unable to complete the form(s) and thus self-select to decline to return the paperwork.
- Actively suicidal, requiring in-patient treatment for depression, depression related cognitive impairment. (see below)
- High anxiety as part of a post-traumatic stress disorder syndrome or panic disorder (see below)
- Previously enrolled in this trial
- Enrolled in another talking therapy trial
- Inability to understand spoken and/or written English
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
NHS Lanarkshire
Airdrie
NHS Lothian
Edinburgh
NHS Fife
Kirkcaldy
About this study
Official title: POst Stroke Intervention Trial in Fatigue: A Randomised Controlled Trial of a Brief Intervention for Post-stroke Fatigue
The purpose of this study is to assess whether a brief cognitive behavioural intervention for post-stroke fatigue leads to clinically relevant improvements in fatigue after 6 months.
Read the detailed description
Primary Objective
Does a brief cognitive behavioural intervention for post-stroke fatigue lead to clinically relevant improvements in fatigue after 6 months? Fatigue will be assessed using the self-reported Fatigue Assessment Scale (FAS) which has been validated for use in stroke (14). This scale includes both mental and physical fatigue. Our data shows that a difference of approximately 5 points in FAS was associated with a clinically significant difference in people with stroke (15); the literature on stroke patients suggests that a difference in four points on the scale is considered to be 'clinically relevant'. We are conservatively basing our power calculations on a difference between groups of four points in the FAS.
Secondary Objectives
- Does the intervention improve fatigue at 4 months (i.e. immediately after the end of the intervention)?
- Does the intervention improve self-reported mood at 4 months and 6 months? This will be assessed using Patient Health Questionnaire (PHQ-9) (16) and the Generalised Anxiety Disorder (GAD7) (17). At 6 months we will also enquire whether antidepressants or anxiolytics have been prescribed.
- Does the intervention improve stroke specific quality of life including patient reported social participation? This will be assessed using the Modified Short Form of the Stroke Impact Scale (18).
- What is the cost of the intervention, and what is the quality of life adjusted life years (QUALYS)? To assess QUALYS, we will use the Euroquol 5D (5 level version) (21).
- Has the patient returned to work? If so are they working the same hours as prestroke?
Endpoints
Primary Endpoint
The primary outcome is the Fatigue Assessment Scale (19) at 6 months after randomisation. The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke(14). A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
Secondary Endpoints
To answer our secondary objectives, we will collect the following outcome measures
- PHQ-9 and GAD-7 (4 months and 6 months after randomisation).
- Modified Short Form of the Stroke Impact Scale (6 months after randomisation) (18).
- At 4 months and 6 months after randomisation: The EuroQol (EQ-5D-5L) to provide an overall measure of health related quality of life (HRQOL) and to allow a health economic analysis based on quality adjusted life years ((20)). As repeated measures of the EQ-5D-5L are required for assessment of QUALYS; this will be done at baseline, 4 months and 6 months.
- Health costs (Between randomisation and 6 months) For this health economic analysis, we will collect data on costs (visits to the GP, number of admissions to hospital, days in a care home, number of visits from social carers, cost of the therapist delivery time, cost of the supervision time from psychology/psychiatry). This will enable us to perform a health economic analysis which will tell us how much the intervention costs, whether there are savings in usage of health/social care, and what QUALYS are associated with the intervention.
- We will ask the patient to list their medication. We will note any new prescriptions of anxiolytics or antidepressants
- Conditions
- Post-stroke Fatigue
- Being tested
- Experimental: Intervention plus information, Active Comparator: Information only
- Keywords
- Post-stroke fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention plus informationBehavioural
The intervention will include six sessions with a therapist, each separated by two weeks. During the two weeks between sessions, participants will work on the goals identified during the sessions. At the final session, the participants will agree how to maintain any improvements in fatigue. Then there will be a review phone call about 4-6 weeks after completion of the intervention, to check on progress and to offer ongoing encouragement to continue with the changes that have been made during the intervention. The intervention can be delivered by video conferencing as well as by phone.
Active Comparator: Information onlyOther
Participants in this arm will be provided with information about fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Intervention plus information | Experimental | Participants in this arm will receive 6 telephone therapy sessions and 1 booster session. Participants will be followed up at 4 months and 6 months. Receives: Behavioral: Experimental: Intervention plus information |
| Information only | Other | Participants in this arm will receive information only. Participants will be followed up at 4 months and 6 months. Receives: Other: Active Comparator: Information only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale (FAS)
The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke. A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
Measured: 6 months after randomisation
Secondary outcomes (6)
PHQ-9
Questionnaire
Measured: 4 months and 6 months after randomisation
GAD-7
Questionnaire
Measured: 4 months and 6 months after randomisation
Modified Short Form of the Stroke Impact Scale
Questionnaire
Measured: 6 months after randomisation
EuroQuol (EQ-5D-5L)
Questionnaire
Measured: Baseline, 4 months and 6 months after randomisation
Health costs
For this health economic analysis, we will collect data on costs (visits to the GP, number of admissions to hospital, days in a care home, number of visits from social carers, cost of the therapist delivery time, cost of the supervision time from psychology/psychiatry).
Measured: Between randomisation and 6 months
List of patient's medication
We will ask the patient to list their medication. We will note any new prescriptions of anxiolytics or antidepressants
Measured: Between randomisation and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start19 Nov 2018
- Primary completion20 Jan 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-stroke FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, The George Institute for Global Health, Australia, University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Gillian Mead, MB BChir MA MD FRCP, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551327
- Sponsor's protocol ID
- AC17066
- Acronym
- POSITIF
- Status last verified
- May 2024
- First submitted
- 29 May 2018
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mead G, Gillespie D, Barber M, House A, Lewis S, Ensor H, Wu S, Chalder T. Post stroke intervention trial in fatigue (POSITIF): Randomised multicentre feasibility trial. Clin Rehabil. 2022 Dec;36(12):1578-1589. doi: 10.1177/02692155221113908. Epub 2022 Jul 21.
PubMed 35866206Gillespie DC, Barber M, Brady MC, Carson A, Chalder T, Chun Y, Cvoro V, Dennis M, Hackett M, Haig E, House A, Lewis S, Parker R, Wee F, Wu S, Mead G. Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue. Pilot Feasibility Stud. 2020 Jun 15;6:84. doi: 10.1186/s40814-020-00622-0. eCollection 2020.
PubMed 32549995
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POst Stroke Intervention Trial in Fatigue: A Randomised Controlled Trial of a Brief Intervention for Post-stroke Fatigue
- ClinicalTrials.gov ID
- NCT03551327
- Acronym / sponsor ID
- POSITIF / AC17066
- Conditions
- Post-stroke Fatigue
- Keywords
- Post-stroke fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Leeds, The George Institute for Global Health, Australia, University College London Hospitals
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether a brief cognitive behavioural intervention for post-stroke fatigue leads to clinically relevant improvements in fatigue after 6 months.
Detailed description
Primary Objective
Does a brief cognitive behavioural intervention for post-stroke fatigue lead to clinically relevant improvements in fatigue after 6 months? Fatigue will be assessed using the self-reported Fatigue Assessment Scale (FAS) which has been validated for use in stroke (14). This scale includes both mental and physical fatigue. Our data shows that a difference of approximately 5 points in FAS was associated with a clinically significant difference in people with stroke (15); the literature on stroke patients suggests that a difference in four points on the scale is considered to be 'clinically relevant'. We are conservatively basing our power calculations on a difference between groups of four points in the FAS.
Secondary Objectives
- Does the intervention improve fatigue at 4 months (i.e. immediately after the end of the intervention)?
- Does the intervention improve self-reported mood at 4 months and 6 months? This will be assessed using Patient Health Questionnaire (PHQ-9) (16) and the Generalised Anxiety Disorder (GAD7) (17). At 6 months we will also enquire whether antidepressants or anxiolytics have been prescribed.
- Does the intervention improve stroke specific quality of life including patient reported social participation? This will be assessed using the Modified Short Form of the Stroke Impact Scale (18).
- What is the cost of the intervention, and what is the quality of life adjusted life years (QUALYS)? To assess QUALYS, we will use the Euroquol 5D (5 level version) (21).
- Has the patient returned to work? If so are they working the same hours as prestroke?
Endpoints
Primary Endpoint
The primary outcome is the Fatigue Assessment Scale (19) at 6 months after randomisation. The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke(14). A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
Secondary Endpoints
To answer our secondary objectives, we will collect the following outcome measures
- PHQ-9 and GAD-7 (4 months and 6 months after randomisation).
- Modified Short Form of the Stroke Impact Scale (6 months after randomisation) (18).
- At 4 months and 6 months after randomisation: The EuroQol (EQ-5D-5L) to provide an overall measure of health related quality of life (HRQOL) and to allow a health economic analysis based on quality adjusted life years ((20)). As repeated measures of the EQ-5D-5L are required for assessment of QUALYS; this will be done at baseline, 4 months and 6 months.
- Health costs (Between randomisation and 6 months) For this health economic analysis, we will collect data on costs (visits to the GP, number of admissions to hospital, days in a care home, number of visits from social carers, cost of the therapist delivery time, cost of the supervision time from psychology/psychiatry). This will enable us to perform a health economic analysis which will tell us how much the intervention costs, whether there are savings in usage of health/social care, and what QUALYS are associated with the intervention.
- We will ask the patient to list their medication. We will note any new prescriptions of anxiolytics or antidepressants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention plus information | Experimental | Behavioral: Experimental: Intervention plus informationParticipants in this arm will receive 6 telephone therapy sessions and 1 booster session. Participants will be followed up at 4 months and 6 months. |
| Information only | Other | Other: Active Comparator: Information onlyParticipants in this arm will receive information only. Participants will be followed up at 4 months and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Stroke 3 months to 2 years previously. Both ischaemic and haemorrhagic, including subarachnoid haemorrhage
- Capacity to consent
- Not living in nursing home.
- Medically stable,
Key exclusion criteria (8 listed)
- Unlikely to be available for follow-up for the next 6 months e.g. no fixed home address
- Other life-threatening illness (e.g. advanced cancer or advanced heart failure) that will make survival for 6 months unlikely
- Aphasia or cognitive impairment which is severe enough to prevent participation in the intervention. To assess this, patients will self-report their language and cognition from the relevant domains in the Short Stroke Impact Scale ('In the past week, how difficult was it for you to think quickly?' and 'In the past week, how difficult was it to understand what was being said to you in a conversation?') Those who respond 'very difficult' or 'could not do at all' to either question will be excluded. (24). Those who might be in these categories are likely to be unable to complete the form(s) and thus self-select to decline to return the paperwork.
- Actively suicidal, requiring in-patient treatment for depression, depression related cognitive impairment. (see below)
- High anxiety as part of a post-traumatic stress disorder syndrome or panic disorder (see below)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention plus informationThe intervention will include six sessions with a therapist, each separated by two weeks. During the two weeks between sessions, participants will work on the goals identified during the sessions. At the final session, the participants will agree how to maintain any improvements in fatigue. Then there will be a review phone call about 4-6 weeks after completion of the intervention, to check on progress and to offer ongoing encouragement to continue with the changes that have been made during the intervention. The intervention can be delivered by video conferencing as well as by phone. | Behavioural | Intervention plus information |
| Active Comparator: Information onlyParticipants in this arm will be provided with information about fatigue. | Other | Information only |
Primary outcome
Fatigue Assessment Scale (FAS)
Time frame: 6 months after randomisation
The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke. A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
6 secondary outcomes
PHQ-9
Time frame: 4 months and 6 months after randomisation
GAD-7
Time frame: 4 months and 6 months after randomisation
Modified Short Form of the Stroke Impact Scale
Time frame: 6 months after randomisation
EuroQuol (EQ-5D-5L)
Time frame: Baseline, 4 months and 6 months after randomisation
Health costs
Time frame: Between randomisation and 6 months
List of patient's medication
Time frame: Between randomisation and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 35866206Mead G, Gillespie D, Barber M, House A, Lewis S, Ensor H, Wu S, Chalder T. Post stroke intervention trial in fatigue (POSITIF): Randomised multicentre feasibility trial. Clin Rehabil. 2022 Dec;36(12):1578-1589. doi: 10.1177/02692155221113908. Epub 2022 Jul 21.
- Derived from this study: PubMed 32549995Gillespie DC, Barber M, Brady MC, Carson A, Chalder T, Chun Y, Cvoro V, Dennis M, Hackett M, Haig E, House A, Lewis S, Parker R, Wee F, Wu S, Mead G. Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue. Pilot Feasibility Stud. 2020 Jun 15;6:84. doi: 10.1186/s40814-020-00622-0. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Post-stroke Fatigue
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Effect of a Multidimensional Intervention Programme on Post-stroke Fatigue
Stroke
Recruiting
Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
Aphasia Following Cerebral Infarction, Stroke Ischemic
Recruiting
Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
Stroke
RecruitingPhase 2
Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue
Stroke, Stroke, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gillian Mead, MB BChir MA MD FRCP principal investigator
University of Edinburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention plus information and Active Comparator: Information only in people with Post-stroke Fatigue, run by University of Edinburgh at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Assessment Scale (FAS) (time frame: 6 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.