ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000042347

Ethics application status

Approved

Date submitted

9/01/2008

Date registered

29/01/2008

Date last updated

18/02/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

From rehabilitation to recovery: A model to optimise consumer and carer involvement in the first year post stroke

Scientific title

The first year after stroke: the efficacy of an intergrated approach aimed at facilitating stroke survivors and their carers to achieve personal goals in order to reduce post stroke depression and improve quality of life, compared to usual patient care approach.

Secondary ID [1]

SVHM1

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Depression

Quality of Life

Carer burden

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Collaborative goal setting with the patient and carer prior to discharge from rehabilitation.
Monitoring of goal achievement and barriers to goal achievement.
Collaborative problem solving to overcome barriers.
Facilitated referral to health and community agencies, tailored to needs.
Promotion of healthy and active lifestyles.
Promotion of self efficacy and self reliance.
Providing targeted carer support through information provision, emotional support and practical support tailored to needs over a 12 month period.
Minimum of four interventions, maximum twelve.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Usual care plus phone contact with an allied health practitioner on three occasions for general support and encouragement.

Control group

Active

Outcomes

Primary outcome [1]

Mean Assessment of Quality of Life score for carers

Timepoint [1]

6 and 12 months after stroke

Primary outcome [2]

Mean Geriatric Depression Scale score for stroke survivors

Timepoint [2]

Baseline (discharge from rehabilitation admission), 6 and 12 months after stroke

Secondary outcome [1]

Zarit Caregiver Burden Scale - carers

Timepoint [1]

6 and 12 months after stroke

Secondary outcome [2]

Functional Independence Measure (motor subset)

Timepoint [2]

Baseline, 6 and 12 months post stroke

Secondary outcome [3]

Minimental State Examination - stroke survivors

Timepoint [3]

Baseline, 6 and 12 months post stroke

Secondary outcome [4]

London Handicap Scale - stroke survivors

Timepoint [4]

Baseline, 6 and 12 months post stroke

Secondary outcome [5]

Activity Card Sort - stroke survivors

Timepoint [5]

Baseline, 6 and 12 months post stroke

Secondary outcome [6]

Strategies Used by People to Promote Health Scale - stroke survivors

Timepoint [6]

Baseline, 6 and 12 months post stroke

Eligibility

Key inclusion criteria

Patient admitted for rehabilitation with a primary diagnosis of acute stroke.
Carers

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Discharge from rehabiliation to nursing home.
Primary cause of disabilities is a diagnosis other than stroke.
Living more than one hour travel time from St.Vincent's Health Melbourne.

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)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/03/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Auatralian Research Council (ARC)

Address [1]

GPO Box 2702
Canberra
ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

St.Vincent's Health Melbourne

Address

PO Box 2900
Fitzroy
Victoria 3065

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Melbourne

Address [1]

Faculty of Medicine Dentistry and Health Sciences
Grattan Street
Parkville
Victoria 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St.Vincent's Health Melbourne

Ethics committee address [1]

PO Box 2900
Fitzroy
Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/12/2007

Approval date [1]

Ethics approval number [1]

162/07

Summary

Brief summary

Despite an acknowledgement of the significance of carer support and consumer involvement in recovery, to date there is a lack of empirical evidence regarding their impact on the outcome of rehabilitation programs for stroke patients.  The aim of this study is to develop a consumer and carer centred model to assist with recovery and community reintegration in the first year after the onset of stroke.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Christine Graven

Address

Physiotherapy Department
St.Vincent's Health Melbourne
PO Box 2900
Fitzroy 3065
Victoria

Country

Australia

Phone

(03) 9288 3827

Fax

Email

[email protected]

Contact person for scientific queries

Name

Christine Graven

Address

Physiotherapy Department
St.Vincent's Health Melbourne
PO Box 2900
Fitzroy 3065
Victoria

Country

Australia

Phone

(03) 9288 3827

Fax

Email

[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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	From rehabilitation to recovery: Protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke.	2011	https://dx.doi.org/10.1186/1471-2377-11-73
Embase	First year after stroke: An integrated approach focusing on participation goals aiming to reduce depressive symptoms.	2016	https://dx.doi.org/10.1161/STROKEAHA.116.013081

N.B. These documents automatically identified may not have been verified by the study sponsor.