Very Early Rehabilitation or Intensive Telemetry After Stroke (VERITAS)
| ISRCTN | ISRCTN23817752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23817752 |
| Secondary identifying numbers | 05/MRE00/90 |
- Submission date
- 27/08/2008
- Registration date
- 30/09/2008
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Langhorne
Scientific
Scientific
Academic Section of Geriatric Medicine
Level 3, University Block
Royal Infirmary
Glasgow
G31 2ER
United Kingdom
Study information
| Study design | Single-blind, factorial (2 x 2) pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Very Early Rehabilitation or Intensive Telemetry After Stroke (VERITAS): a pilot randomised controlled trial |
| Study acronym | VERITAS |
| Study objectives | Very early rehabilitation or intensive monitoring will reduce complications and improve patient recovery after stroke. |
| Ethics approval(s) | Ethics Committee Scotland (A) MREC. Date of approval: 22/12/2005 (ref: 05/MRE00/90) |
| Health condition(s) or problem(s) studied | Acute stroke |
| Intervention | The participants were randomly allocated to the following four arms: 1. Standard care: Early transfer to an established multidisciplinary stroke unit where they will receive conventional stroke unit care within an established stroke service 2. Early mobilisation plus standard care: The early mobilisation interventions are based on the AVERT trial (see below), and will begin within 24 hours of the onset of the symptoms. The protocol is functional and task specific and can be summarised as follows: a. Mobilisation should commence as soon as possible on the stroke unit b. Bedrest should be avoided if at all possible c. Patients will be encouraged to be up, sitting and transferring at least 4 times per day d. Any vulnerable hemioplegic shoulder will be cared for using supports when sitting, transferring and walking The primary objective is to increase the frequency of mobilisation. The protocol will be delivered by the research nurse, under the supervision of a trained physiotherapist. During the first 3 days after stroke the stroke patients will be observed closely for abnormalities of heart rate, oxygen saturation and blood pressure during mobilisation. If there are any abnormalities during these procedures, mobilisation will be discontinued. The five stages for monitoring are as follows: i. Before mobilisation (lying in bed) ii. Sitting upright in bed iii. Sitting on the edge of the bed iv. After five minutes sitting on the edge of the bed v. After transferring to a chair The duration of each early mobilisation intervention will be determined by the patient tolerance but will range between 5 and 30 minutes per session. The research nurse trained in the intervention will be available on the ward during weekdays as will be supervising physiotherapist. The intervention will continue for at least 7 days or until discharge whichever is sooner. 3. Automated physiological monitoring: Standard care plus a protocol based on the Gateshead trial (see below) guiding the continuous monitoring. This will use an established commercial system (Welch Allyn Inc), which will include the possibility of ambulatory monitoring. The protocol will include advice on responding to abnormalities of heart rate or rhythm, blood pressure, temperature, oxygen level or blood glucose. Routine monitoring will be continued for the first three days and extended beyond then if persisting abnormalities are identified. After this time patients will revert to standard care. The research nurse will devote time to ensuring the monitoring protocol is followed. 4. A combined protocol incorporating both 2 and 3 above Total duration of interventions: 1 week Total duration of follow-up: 3 months Information on the AVERT trial can be found at http://www.ncbi.nlm.nih.gov/pubmed/18706042 Information on the Gateshead trial can be found in the 1998 British Geriatrics Society autumn meeting abstract (http://www.ncbi.nlm.nih.gov/pubmed/10450456) - Davis M, Hollyman C, McGiven M, Chambers I, Egbuji J, Barer D. Physiological monitoring in acute stroke. Age Ageing 1999 (Suppl):P33 |
| Intervention type | Other |
| Primary outcome measure | The following will be monitored for 7 days: 1. Feasibility (especially treatment contamination) 2. Acceptability of the trial process 3. Safety of the trial process: early complications and adverse events Note: The primary outcome of the proposed main trial will be the proportion of patients dead or disabled (Modified Rankins Score 3-5) at 3 months post stroke. |
| Secondary outcome measures | Patient activity, recorded for 7 days using automated activity monitors which record the time spent lying, sitting, standing or walking. |
| Overall study start date | 01/03/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | Individuals (both males and females) admitted to hospital with symptoms of new stroke within 24 hours of symptom onset (with the primary objective of recruiting individuals within 12 hours of symptom onset). |
| Key exclusion criteria | 1. Individuals with severe pre-stroke disability 2. Those who have made a full recovery 3. Severe comorbidities which would prevent their participation in the trial |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Academic Section of Geriatric Medicine
Glasgow
G31 2ER
United Kingdom
G31 2ER
United Kingdom
Sponsor information
Greater Glasgow and Clyde NHS Board (UK)
Hospital/treatment centre
Hospital/treatment centre
East Research Office
Glasgow Royal Infirmary
4th Floor Walton Building
84 Castle Street
Glasgow
G4 0SF
Scotland
United Kingdom
| Website | http://www.nhsggc.org.uk |
|---|---|
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Charity
Chest, Heart and Stroke Scotland (Ref: 05/A87)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of pilot study | 01/09/2010 | Yes | No |
Editorial Notes
27/09/2017: internal review.
