Condition category
Mental and Behavioural Disorders
Date applied
16/10/2013
Date assigned
13/02/2014
Last edited
03/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Protected engagement time (PET) is an initiative adopted in some dementia wards in England. It is in response to feedback that ward staff may to be able to spend enough time with people suffering from dementia. The aim is to help ward staff to be able to prioritise this by reorganising ward routines so they can engage with patients individually or in groups. It is expected that, as a result, patients service users will experience less distress and require less psychiatric medication. The aim of this study is to examine whether the quality of life of patients is increased on wards where PET is implemented and whether it has any impact on other aspects of how patients and staff experience being on the wards.

Who can participate?
Patients who have been inpatients on the participating dementia wards for fourteen or more days will be eligible to take part. Relatives and staff will also be invited to take part.

What does the study involve?
There are a number of parts to the study. We will carry out a national telephone survey of all the dementia inpatient wards in England to find out where and how PET is being implemented. Ten wards over the three sites selected for the study have agreed to take part in providing information about life on the ward. Five of these wards offer PET whilst the other five do not. Measures will be taken from patients, relatives and staff on these participating wards through recognised questionnaires. We will also be speaking with and interviewing a number of patients, staff and relatives from PET wards to get more in-depth information about their views of PET. Finally we will devise a fidelity measure (to which extent the initiative is delivered as intended) from all the data collected from the other parts of the study.

What are the possible benefits and risks of participating?
Benefits include patients, staff and relatives having their views and experiences taken into consideration, helping to shape service developments. We do not anticipate many risks to taking part in the study but participants may become distressed during questioning. Researcher will be well trained to manage such situations should they occur. Participants will be able to complete the questionnaires and interviews in stages if required.

Where is the study run from?
The University of the West of England, Bristol is running the study. There are three participating sites: Avon and Wiltshire Mental Health Partnership NHS Trust, Norfolk and Suffolk Foundation Trust and Camden and Islington Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
June 2013 to April 2015

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof Richard Gray, Chief Investigator
Miss Emily Dodd, Trial Manager, emily3.dodd@uwe.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Emily Dodd

ORCID ID

Contact details

Faculty of Health & Life Sciences
University of the West of England (UWE)
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
-
emily3.dodd@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14879

Study information

Scientific title

A preliminary comparison of wards for people with dementia using patient Protected Engagement Time (PET), with other wards delivering standard care alone

Acronym

PET-Dementia

Study hypothesis

We wish to examine whether the quality of life of patients is increased on wards where PET is implemented and whether it has any impact on other aspects of how patients and staff experience being on the wards.

Ethics approval

London - Camden and Islington NRES Ethics Committee, 25/03/2013, ref: 13/LO/0191

Study design

Non-randomised mixed methodology design observational study single time point

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia;
Disease: Dementia

Intervention

1. National telephone survey of all dementia inpatient wards in England to gather a detailed picture of the implementation of PET across the country
2. Administration of questionnaires to staff, patients and relatives on ten participating wards over three sites; five wards where PET is implemented (PET wards) and five wards (non-PET wards) delivering standard care alone

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Quality of Life (DEMQOL) which measures health-related quality of life of people with dementia; Timepoint(s): Single observation at trial entry
2. Qualitative interviews with a sample of staff, patients and relatives from participating PET wards

Secondary outcome measures

1. Patients:
1.1. Client satisfaction questionnaire
1.2. Camden Content of Care questionnaire
1.3. EuroQol EQ-5D
2. Staff:
2.1. Maslach Burnout Inventory
2.1. Ward Atmosphere Scale
3. Relatives:
3.1. Carer burden

Patients and staff on PET wards will also be asked specific questions about their experience of PET. All measures are taken once. There is no follow up.

Overall trial start date

26/07/2013

Overall trial end date

31/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients with dementia who have been in hospital for fourteen days or more will be eligible to be included in this study as this will allow an adequate period in which to have experienced life on the ward.
2. Target Gender: Male & Female
3. Lower Age Limit 65 years

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 596; UK Sample Size: 596

Participant exclusion criteria

There are no exclusions listed.

Recruitment start date

26/07/2013

Recruitment end date

31/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of the West of England (UWE)
Bristol
BS16 1DD
United Kingdom

Sponsor information

Organisation

Norfolk and Waveney Mental Health NHS Foundation Trust (UK)

Sponsor details

80 St. Stephens Road
Norwich
NR1 3RE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - CCF; Grant Codes: PB-PG-0110-21023

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

2015 protocol in: http://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-016-0049-z

Publication citations

Additional files

Editorial Notes

03/02/2016: Publication reference added.