Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000799459
Ethics application status
Approved
Date submitted
13/06/2016
Date registered
20/06/2016
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a stroke self-management program for people with mild stroke discharged home improve recovery outcomes as compared to usual care?
Scientific title
Mild Stroke: Enhancing and Guiding Transition Home
Secondary ID [1] 287466 0
Nil known
Universal Trial Number (UTN)
U1111-1174-3557
Trial acronym
MiStrEnGTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebrovascular Accident (Stroke) 296194 0
Condition category
Condition code
Stroke 296469 296469 0 0
Ischaemic
Stroke 296470 296470 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A stroke self-management program (SSMP) delivered using telehealth for individuals with mild stroke who are discharged home after acute stroke management only. Five telephone-based sessions of between 30 and 60 minutyes will be provided during the first 6 months after stroke. During these phone-based sessions the therapist will speak to both the person with stroke and the carer. The sessions will occur 1-, 4- and 8-weeks post hospital discharge, with the final 2 sessions scheduled based on the needs of the person with stroke within the first 6 month period. The SSMP program will be tailored to the individual needs of the person with stroke and their family. Each session will follow a pre-developed framework which includes the following:
1. Reflection: an opportunity to reflect on areas of change in their life since stroke including acknowledgement on progress and achievements.
2. Management: Identification of areas of life that have been impacted upon by the stroke through in-depth discussion followed by unmet needs from community or rehabilitation services.
3. Goal-planning: Information discussed in the reflection and management stages of the sessions will be used to guide to goal-planning. Goal planning will occur with both the person with stroke and their family as required. It will use a shared decision making process and / or motivational interviewing framework in order to develop the goals and then plan the actions required to achieve the goals.
4. Education: Educational needs related to stroke identified during the session will also be addressed through the therapist providing verbal information +/- directing the person to available resources (e.g. stroke support groups, Stroke Foundation websites).
At the conclusion of each session the therapist will send the person with stroke and family as required a copy of the developed goals and the action plans associated with them, as well as any written information or website links that might assist the person in achieving their goals or addressing educational needs. Email will be the preferred mode of delivering this information.
The SSMP will be provided in addition to usual care processes on an individual basis. The program will be delivered by an allied health professional with extensive experience in the management of people with stroke.
Intervention code [1] 292842 0
Rehabilitation
Comparator / control treatment
Standard treatment will be provided which may include stroke education, discharge report to patient's general practitioner, follow-up stroke clinic appointment 1 to 3 months post-stroke, and referral to services as required.
Stroke Education will at a minimum involves provision of a hard copy booklet on hospital discharge known as "My Stroke Journey" which has been developed by the National Stroke Foundation, Australia. Modules within this package are:
1. About Stroke (including information about: What is a stroke? Types of stroke; How a stroke can affect you)
2. Reduce your risk
3. Rehabilitation and leaving hospital
4. Carer information
5. Further information (including information about where to get more help, websites, list of available fact sheets)
Control group
Active

Outcomes
Primary outcome [1] 296097 0
Assessment of Quality of Life 6D (AQoL-6D)
Timepoint [1] 296097 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post-stroke
Primary outcome [2] 296098 0
Depression Anxiety and Stress Scale-21 items (DASS-21)
Timepoint [2] 296098 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post stroke
Secondary outcome [1] 317481 0
Re-integration to Normal Living Index
Timepoint [1] 317481 0
1-week post discharge, 3-months post-stroke and 6-months post stroke
Secondary outcome [2] 317483 0
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Timepoint [2] 317483 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post-stroke
Secondary outcome [3] 317485 0
Confidence after Stroke Measure (CASM)
Timepoint [3] 317485 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post-stroke
Secondary outcome [4] 317486 0
Patient Competency Rating Scale (PCRS)
Timepoint [4] 317486 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post-stroke
Secondary outcome [5] 317487 0
Service Satisfaction Visual Analogue Scale
Timepoint [5] 317487 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post-stroke
Secondary outcome [6] 317489 0
Carer Strain Index (CSI)
Timepoint [6] 317489 0
Hospital discharge, 1-week post discharge, 3-months post-stroke, and 6-months post-stroke

Eligibility
Key inclusion criteria
Stroke participants
- admitted with a confirmed new onset mild stroke
- receive acute hospital management only
- discharge destination is home or a community environment

Carers of the stroke participant
- provide informal assistance / support to a participant in the stroke group
- assistance / support role will likely be ongoing during the course of the study
- over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stroke participants
- inadequate language or cognition to provide informed consent and / or complete outcome measures
- discharged to residential care facility or other healthcare facility
- existing comorbidites likely to limit participation in program (e.g. dementia or severe mental illness)

Carers of the stroke participants
- inadequate language or cognition to provide informed consent and / or complete outcome measures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/01/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
22/12/2017
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5962 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 5963 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13384 0
4032 - Chermside
Recruitment postcode(s) [2] 13385 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 293797 0
Government body
Name [1] 293797 0
Allied Health Professionals Office Queensland
Country [1] 293797 0
Australia
Funding source category [2] 293798 0
Charities/Societies/Foundations
Name [2] 293798 0
National Stroke Foundation
Country [2] 293798 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
627 Rode Rd, Chermside Qld 4032
Country
Australia
Secondary sponsor category [1] 292631 0
Hospital
Name [1] 292631 0
Royal Brisbane and Women's Hospital
Address [1] 292631 0
Butterfield St, Herston, Qld 4029
Country [1] 292631 0
Australia
Other collaborator category [1] 279034 0
University
Name [1] 279034 0
The University of Queensland
Address [1] 279034 0
St Lucia Campus, St Lucia Qld 4072
Country [1] 279034 0
Australia
Other collaborator category [2] 279035 0
University
Name [2] 279035 0
Australian Catholic University
Address [2] 279035 0
McAuley Campus,
1100 Nudgee Road
Banyo Queensland 4014
Country [2] 279035 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295231 0
The Prince Charles Hospital Human Research and Ethics Committee
Ethics committee address [1] 295231 0
627 Rode Rd, Chermside Qld 4032
Ethics committee country [1] 295231 0
Australia
Date submitted for ethics approval [1] 295231 0
09/06/2015
Approval date [1] 295231 0
27/08/2015
Ethics approval number [1] 295231 0
HREC/15/QPCH/18

Summary
Brief summary
Major issues impacting survivors of stroke & their carers are reduced quality of life & depression. The period of transition from hospital to home is a critical time for recovery for survivors of mild stroke; bridging hospital discharge to community integration. It has been identified that stroke survivors feel ill-prepared mentally and physically to return to their lives after discharge from hospital (Cott et al., 2007; Turner et al., 2009; Rittman,
Boylstein, Hinojosa et al., 2007). A discharge care plan developed by the stroke team focusing on the needs & goals of the person with stroke facilitates the transition home inclusive of medical management, ongoing rehabilitation, and education around lifestyle modification. However, a recent clinical audit of the Australian facilities revealed that less
than 50% of survivors of stroke discharged from acute care received this (National Stroke Foundation, 2014).
Survivors of mild stroke, typically present with minimal impairments & are often discharged home without inpatient rehabilitation. Recent research highlights that the impact of stroke only becomes obvious on returning home when re-engaging in previous life roles (e.g. work, leisure).
The overarching aim of this research is to determine the efficacy of a new allied healthled
model of care for individuals with mild stroke discharged from acute care. The primary aim is to assess the efficacy of MiStrEnGTH as compared to usual care on quality of life (QoL) and client mood. A secondary aim is to assess the efficacy of MiStrEnGTH as compared to usual care on daily activity, community participation, carer mood and strain. It is hypothesized that clients and carers receiving MiStrEnGTH will have improved QoL, mood and community participation, with lower levels of carer strain as compared to usual care.
A study design of a randomized controlled trial with intention-to-treat analysis will be used. All participants with acute mild stroke will be randomized to one of two intervention arms at discharge: 1) control 'standard care'; 2) intervention 'MiStrEnGTH'. Data collection from participants will occur at baseline (recruitment), and 1-, 3- and 6-months post-discharge from hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60306 0
A/Prof Petrea Cornwell
Address 60306 0
Allied Health Research Collaborative
The Prince Charles Hospital
627 Rode Rd, Chermside Qld 4032
Country 60306 0
Australia
Phone 60306 0
+61 7 3139 6112
Fax 60306 0
N/a
Email 60306 0
[email protected]
Contact person for public queries
Name 60307 0
A/Prof Petrea Cornwell
Address 60307 0
Allied Health Research Collaborative
The Prince Charles Hospital
627 Rode Rd, Chermside Qld 4032
Country 60307 0
Australia
Phone 60307 0
+61 7 3139 6112
Fax 60307 0
Email 60307 0
[email protected]
Contact person for scientific queries
Name 60308 0
A/Prof Petrea Cornwell
Address 60308 0
Allied Health Research Collaborative
The Prince Charles Hospital
627 Rode Rd, Chermside Qld 4032
Country 60308 0
Australia
Phone 60308 0
+61 7 3139 6112
Fax 60308 0
Email 60308 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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