POst Stroke Intervention Trial In Fatigue (POSITIF)

NCT03551327 | Completed DMC

• 1 other identifier: AC17066
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Post-stroke Fatigue

Keywords

Post-stroke fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after randomisation

Secondary Outcomes (6)

• PHQ-9

  4 months and 6 months after randomisation

• GAD-7

  4 months and 6 months after randomisation

• Modified Short Form of the Stroke Impact Scale

  6 months after randomisation

• EuroQuol (EQ-5D-5L)

  Baseline, 4 months and 6 months after randomisation

• Health costs

  Between randomisation and 6 months

Study Arms (2)

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.

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.

Other: Active Comparator: Information only

Interventions

Experimental: Intervention plus information BEHAVIORAL

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.

Intervention plus information

Active Comparator: Information only OTHER

Participants in this arm will be provided with information about fatigue.

Information only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• University of Leeds: collaborator
• The George Institute for Global Health, Australia: collaborator
• University College London Hospitals: collaborator

Study Sites (3)

NHS Lanarkshire

Airdrie, United Kingdom

Location

NHS Lothian

Edinburgh, United Kingdom

Location

NHS Fife

Kirkcaldy, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35866206 RESULT

• Gillespie 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.

  PMID: 32549995 DERIVED

Study Officials

• Gillian Mead, MB BChir MA MD FRCP

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The patient and the person delivering the intervention will not be blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: November 19, 2018
• Primary Completion: January 20, 2020
• Study Completion: July 31, 2021
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)