Condition category
Circulatory System
Date applied
04/03/2011
Date assigned
04/03/2011
Last edited
12/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Susan Campbell

ORCID ID

Contact details

School of Nursing Science
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
-
susan.campbell@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8188

Study information

Scientific title

An exploratory randomised controlled trial of a DEPression Recognition and Treatment package for families living with STROKE

Acronym

DEPRET-STROKE

Study hypothesis

Evaluate whether families after stroke who are treated with the Depression Recognition and Treatment package in Stroke (DepReT-Stroke) in addition to treatment as usual (TAU) show improved mental well being compared to those families who receive only TAU.

On 28/04/2014 the anticipated end date was changed from 01/08/2013 to 02/01/2015.
On 12/02/2015 the overall trial date was changed from 03/01/2011 to 03/01/2014. Recruitment start and end dates were also added.

Ethics approval

10/H0310/23; First MREC approval date 20/04/2010

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Depression; Disease: Depression

Intervention

DepReT-Stroke, Six session with a trained study nurse delivered at fortnightly intrvals plus two booster sessions.; Follow Up Length: 6 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mental Component Summary of the SF-36v2; Timepoint(s): Six months

Secondary outcome measures

Beliefs about Medicines Questionniare (BMQ); Timepoint(s): 6 months; Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 6 months; Knowledge of Depression Multiple Choice Question Test; Timepoint(s): 6 months

Overall trial start date

03/01/2012

Overall trial end date

02/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 28/04/2014:
1. Patient diagnosed with ischaemic or haemorrhagic stroke
2. Stroke type confirmed
3. Patient identified by a participating NHS Trust
4. Patient diagnosed with a stroke between 1 month and 5 years ago.
5. Patient has been living at home for not less than 2 weeks
6. Patient has a self-defined ‘primary carer’
7. Patient and/or carer scores as depressed on any clinical tool used to identify depression in clinical practice
8. Patient and carer over 18 years of age (no upper age limit)

Previous inclusion criteria:
1. Patient diagnosed with ischaemic or haemorrhagic stroke
2. Stroke type confirmed by computerised tomography scan
3. Patient listed in the NNUH Stroke Register
4. Patient diagnosed with a stroke for at least three months.
5. Patient has been living at home for not less than two weeks
6. Patient has a self defined ‘primary carer’.
7. Patient and/or carer scores =8 on the Hospital Anxiety and Depression Scale (HADS)
8. Patient and carer aged between 18-110 years of age
We have stipulated the widest possible age range for eligibility as the DepReTStroke package will be designed to be as inclusive as possible and accommodate the needs of persons with stroke and their carers irrespective of age.

Target Gender: Male & Female; Upper Age Limit 110 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 126; UK Sample Size: 126

Participant exclusion criteria

1. Serious or unstable medical conditions (e.g. advanced/incurable cancer; severe comorbidity or severe unpredictable pain)
2. Psychosis or other severe mental illness
3. Suicidal thoughts or ideation
4. Dementia
5. Institutionalised (e.g. care home resident)
6. Participating in any other research concerning stroke or depression

Added 28/04/2014:
7. Current treatment for depression (anti-depressant medication or talking therapies)

Recruitment start date

10/12/2012

Recruitment end date

02/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Nursing Science
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospital NHS Trust (UK)

Sponsor details

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
-
rdoffice@nnuh.nhs.uk

Sponsor type

University/education

Website

http://www.nnuh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21529370

Publication citations

  1. Protocol

    Gray RJ, Myint PK, Elender F, Barton G, Pfeil M, Price G, Wyatt N, Ravenhill G, Thomas E, Jagger J, Hursey A, Waterfield K, Hardy S, A Depression Recognition and Treatment package for families living with Stroke (DepReT-Stroke): study protocol for a randomised controlled trial., Trials, 2011, 12, 105, doi: 10.1186/1745-6215-12-105.

Additional files

Editorial Notes