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SPRITE - A Feasibility and Pilot Study (SPRITE)

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ClinicalTrials.gov Identifier: NCT02712385
Recruitment Status : Unknown
Verified June 2017 by Prof Frank Kee, Queen's University, Belfast.
Recruitment status was:  Recruiting
First Posted : March 18, 2016
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Prof Frank Kee, Queen's University, Belfast

Brief Summary:

BACKGROUND - Approximately 1,700 transient ischaemic attacks (TIAs) occur annually in NI with TIA survivors often being left with considerable functional impairment. TIA and strokes share common risk factors with cardiovascular disease. Cardiac rehabilitation post-myocardial infarction has shown significant reductions in morbidity and mortality, with home-based programmes producing better adherence and similar outcomes to hospital-and community-based programmes. However, the value of rehabilitation programmes for stroke prevention following a TIA or minor stroke is unclear.

AIMS - to determine if a novel rehabilitation programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients can be developed, using MRC guidelines for developing complex health service interventions, from an approved home-based cardiac rehabilitation programme (the 'Heart Manual') and to undertake feasibility and pilot studies of the novel programme.

METHODS-All patients attending a TIA clinic in Belfast within 4 weeks of their first TIA/mild stroke will be invited to participate. The novel home-based programme manual will be developed following systematic reviews of the literature and qualitative exploration with the target population, using focus groups. A feasibility study will initially be undertaken lasting 6 weeks and then developed into a pilot trial of 12 weeks duration. The feasibility will recruit to 3 different treatments: (1) standard care; (2) standard care plus the manual; (3) standard care, manual plus a pedometer. Whilst for the pilot study there will also be 3 arms but this will include: 1) control group; 2) manual and pedometer supported by telephone follow-up with a GP; 3) manual and pedometer supported by telephone follow-up with a stroke nurse. Interviews and focus groups will be employed to assess the interventions' acceptability. The intervention, 'The Healthy Brain Rehabilitation Manual' will be refined and modified at all stages of the research.

CONCLUSIONS - The findings will inform the development of a novel secondary prevention programme, 'The Healthy Brain Rehabilitation Manual', for TIA/minor stroke patients and of a trial to test its effectiveness and longer-term potential to improve outcomes for TIA/stroke patients.


Condition or disease Intervention/treatment Phase
Cerebrovascular Disorders Other: 'The Healthy Brain Rehabilitation Manual' Device: Pedometer Procedure: Usual care Behavioral: Telephone follow-up Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention groups will be getting access to a home-based rehabilitation, 'The Healthy Brain Rehabilitation Manual', telephone follow-up with either a GP or stroke nurse and a pedometer.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stroke Prevention Rehabilitation Intervention Trial of Exercise - SPRITE - A Feasibility and Pilot Study
Study Start Date : March 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Control - usual care
Usual post-TIA/minor stroke care as per current healthcare system protocol will be given to patients in control group and details will be recorded.
Active Comparator: Manual
Receiving usual post-TIA/minor stroke care plus 'The Healthy Brain Rehabilitation Manual'.
Other: 'The Healthy Brain Rehabilitation Manual'
The Healthy Brain Rehabilitation Manual is a home-based rehabilitation manual developed for the post-TIA and minor stroke population caused by ischaemic events. The manual addresses all the secondary prevention factors required post-ischaemic TIA/minor stroke, e.g. smoking cessation, physical activity promotion.

Procedure: Usual care
Usual care provided by healthcare system for patients who suffer a TIA or minor stroke will be recorded and form 'active comparator' control.

Active Comparator: Manual + pedometer, 1
Receiving usual post-TIA/minor stroke care plus 'The Healthy Brain Rehabilitation Manual' and a pedometer with telephone follow-up from a General Practitioner.
Other: 'The Healthy Brain Rehabilitation Manual'
The Healthy Brain Rehabilitation Manual is a home-based rehabilitation manual developed for the post-TIA and minor stroke population caused by ischaemic events. The manual addresses all the secondary prevention factors required post-ischaemic TIA/minor stroke, e.g. smoking cessation, physical activity promotion.

Device: Pedometer
Pedometer used to measure step counts as an objective measurement of level of physical activity.

Procedure: Usual care
Usual care provided by healthcare system for patients who suffer a TIA or minor stroke will be recorded and form 'active comparator' control.

Behavioral: Telephone follow-up
Telephone follow-up by either a General Practitioner (GP) or Stroke nurse.

Active Comparator: Manual + pedometer, 2
Receiving usual post-TIA/minor stroke care plus 'The Healthy Brain Rehabilitation Manual' and a pedometer with telephone follow-up from a Stroke nurse.
Other: 'The Healthy Brain Rehabilitation Manual'
The Healthy Brain Rehabilitation Manual is a home-based rehabilitation manual developed for the post-TIA and minor stroke population caused by ischaemic events. The manual addresses all the secondary prevention factors required post-ischaemic TIA/minor stroke, e.g. smoking cessation, physical activity promotion.

Device: Pedometer
Pedometer used to measure step counts as an objective measurement of level of physical activity.

Procedure: Usual care
Usual care provided by healthcare system for patients who suffer a TIA or minor stroke will be recorded and form 'active comparator' control.

Behavioral: Telephone follow-up
Telephone follow-up by either a General Practitioner (GP) or Stroke nurse.




Primary Outcome Measures :
  1. Rate of recruitment [ Time Frame: 12 weeks (pilot study) ]
    Recruitment rate calculated as percentage of potentially eligible patients who agree to participate


Secondary Outcome Measures :
  1. Change in Level of physical activity [ Time Frame: Baseline to 12 weeks ]
    Physical activity measured as step count (steps/day) assessed at baseline and 12 weeks, to determine extent of change. Also accelerometer data over the same timeframe.

  2. Change in Body Mass Index (BMI) [ Time Frame: Baseline to 12 weeks ]
    BMI measured at baseline and 12 weeks, to determine extent of change

  3. Change in Quality of life [ Time Frame: Baseline to 12 weeks ]
    Quality of life assessed at baseline and 12 weeks, to determine extent of change

  4. Change in Blood pressure [ Time Frame: Baseline and 12 weeks ]
    Systolic and diastolic blood pressure measured at baseline and 12 weeks.

  5. Change in Physical function [ Time Frame: Baseline and 12 weeks ]
    Distance walked in two minutes assessed by the two minute walk test at baseline and 2 weeks to determine extent of change in measurement

  6. Rate of retention [ Time Frame: 12 weeks ]
    Numbers of patients who complete review assessments at 12 weeks, expressed as percentage of those who agree to participate and attend baseline assessment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • male or female
  • attendee at a participating TIA clinic within 4 weeks of a first suspected TIA
  • diagnosed with a TIA or 'minor' stroke, due to atherosclerosis or small vessel occlusion (diagnosis based on the TOAST classification system (69)(70), following neurological examination and neuroimaging (32)).

Exclusion Criteria:

  • patients who have experienced more than one TIA and/or stroke
  • inability to give informed consent
  • presenting after 4 weeks of their first suspected TIA and/or 'minor' stroke
  • contra-indication for exercise training, based on guidelines of the American College of Sports Medicine(72)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712385


Contacts
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Contact: Neil Heron, MRCGP,FFSEM 0791771 ext 6425 nheron02@qub.ac.uk
Contact: Frank Kee, MRCGP, MD 07718807 ext 640 f.kee@qub.ac.uk

Locations
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United Kingdom
Ulster Hospital Recruiting
Belfast, Antrim, United Kingdom, BT16 1RH
Contact: David Wilson, Consultant    0289048 ext 4511      
Antrim Area Not yet recruiting
Antrim, United Kingdom, BT41 2RL
Contact: Djamil Vahidassr, MBChB       Djamil.Vahidassr@northerntrust.hscni.net   
Craigavon Area Hospital Not yet recruiting
Craigavon District, United Kingdom, BT63 5QQ
Contact: Michael McCormick, MBChB       Michael.McCormick@southerntrust.hscni.net   
Sponsors and Collaborators
Queen's University, Belfast
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Frank Kee, MRCGP, MD Queen's University, Belfast

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof Frank Kee, Professor of Public Health, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT02712385     History of Changes
Other Study ID Numbers: CDV/5053/14
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be made available
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases