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

ISRCTN	ISRCTN32451749
DOI	https://doi.org/10.1186/ISRCTN32451749
Secondary identifying numbers	8188

Submission date: 04/03/2011
Registration date: 04/03/2011
Last edited: 29/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Susan Campbell
Scientific

School of Nursing Science
University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Email	susan.campbell@uea.ac.uk

Study information

Study design	Randomised interventional treatment
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	An exploratory randomised controlled trial of a DEPression Recognition and Treatment package for families living with STROKE
Study acronym	DEPRET-STROKE
Study objectives	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(s)	10/H0310/23; First MREC approval date 20/04/2010
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	03/01/2012
Completion date	02/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 126; UK Sample Size: 126
Key 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
Key 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)
Date of first enrolment	10/12/2012
Date of final enrolment	02/05/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Nursing Science

Norwich
NR4 7TJ
United Kingdom

Sponsor information

Norfolk and Norwich University Hospital NHS Trust (UK)
University/education

Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom

Email	rdoffice@nnuh.nhs.uk
Website	http://www.nnuh.nhs.uk/
"ROR"	https://ror.org/01wspv808

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

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?
Protocol article	protocol	30/04/2011		Yes	No

Editorial Notes

29/05/2020: No publications found.
29/10/2018: No publications found, verifying study status with principal investigator.