Condition category
Mental and Behavioural Disorders
Date applied
30/07/2010
Date assigned
12/08/2010
Last edited
12/09/2011
Prospective/Retrospective
Retrospectively 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

Prof Eamon O'Shea

ORCID ID

Contact details

School of Business and Public Policy
National University of Ireland Galway
Galway
-
Ireland
Eamon.oshea@nuigalway.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

The DARES Study

Study information

Scientific title

A cluster randomised trial on the effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units

Acronym

DARES (DementiA Education Programme Incorporating REminiscence Therapy for Staff)

Study hypothesis

Aims:
1. To develop a comprehensive structured education reminiscence-based programme for staff (SERPS) that is specifically orientated toward incorporating reminiscence in the care of resident’s with dementia
2. To evaluate the effectiveness of the SERPS within the context of a cluster randomised trial
3. To understand participants’ (staff and people with dementia) perceptions of the SERPS, its impact on their lives and experience of care

Please note that as of 19/10/10 the primary and secondary outcomes sections of this record have been updated. Please also note that these changes have been implemented prior to any post randomisation data collection. More information can be found in the relevant field with the above update date.

Ethics approval

1. The Research Ethics Committee of the National University of Ireland, Galway approved on the 20th of November 2008.
2. Ethics approval was also obtained from the appropriate ethics committees responsible for trials within the selected public clinical sites

Study design

Two arm single blind cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Dementia

Intervention

Staff participants in long-stay units randomised to the experimental arm will attend the DARES structured education reminiscence-based programme for staff (SERPS), which will be delivered over three days; starting with two consecutive days and a third day, 6 weeks later. The DARES research team will provide telephone support to staff participants during the study period (22-25 weeks post randomisation) and will conduct one support visit to each unit within this period.
The SERPS is founded on the DARES programme philosophy of empowerment of staff participants, including identifying what participants perceive to be important and what they feel they need to know. The concepts of learner-centeredness and adult learning are at the core of the programme, and those teaching the programme will adopt a facilitator-participant role, as this is considered central to modelling an empowerment philosophy. Staff participants will be trained to enable them to incorporate reminiscence in the care of residents with dementia.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality of Life of residents as measured by the Quality of Life-AD (QOL-AD) instrument (Logsdon et al 1999).
Current information as of 19/10/10:
All outcomes will be assessed at baseline and at 18 to 22 weeks post randomisation.

Initial information at time of registration:
All outcomes will be measured at baseline and at 22 to 25 weeks post randomisation.

Secondary outcome measures

1. Agitation, measured using the Cohen-Mansfield Agitation Inventory (CMAI)
2. Depression, measured using the Cornell Scale for Depression in Dementia
3. Staff attitudes to residents with dementia and perceived care burden will be assessed using a modified version of the Zarit Burden Interview
Current information as of 19/10/10:
All outcomes will be assessed at baseline and at 18 to 22 weeks post randomisation.

Initial information at time of registration:
All outcomes will be measured at baseline and at 22 to 25 weeks post randomisation.

Overall trial start date

01/12/2008

Overall trial end date

30/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Residents who have lived in the residential unit for at least one month and are likely to be there for the duration of the study
2. Residents with dementia. Diagnosis may be determined in any of the following ways:
2.1. A formal diagnosis of dementia determined by the DSM-1V criteria for dementia (American Psychiatric Association 1995)
2.2. Any other diagnosis of dementia by a medical clinician
2.3. Resident is on anti-Alzheimer’s medications, including Aricept (donepezil), Ebixa (memantine) and Exelon (rivastigmine)
2.4. Nurses’ judgement and/or nursing records advise that the person has dementia

Study sites:
Public and private long-stay units across the Western seaboard of the Republic of Ireland who meet the eligibility criteria will be invited to participate.
1. Have 17 residents with dementia who agree to take part
2. A commitment from management of the long-stay unit and the clinical staff to participate in the study

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

18 residential units (clusters) each containing 17 people with dementia

Participant exclusion criteria

Patients:
1. Has a sensory impairment that, in the judgment of the nursing staff, impairs their ability to participate
2. Has an acute physical illness that, in the judgment of the nursing staff, impairs their ability to participate

Recruitment start date

01/12/2008

Recruitment end date

30/11/2011

Locations

Countries of recruitment

Ireland

Trial participating centre

School of Business and Public Policy
Galway
-
Ireland

Sponsor information

Organisation

Health Research Board (Ireland)

Sponsor details

73 Baggot Street
Dublin
D2
Ireland
hrb@hrb.ie

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Health Research Board (Ireland) (RP/2008/64)

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21320303

Publication citations

  1. Protocol

    O'Shea E, Devane D, Murphy K, Cooney A, Casey D, Jordan F, Hunter A, Murphy E, Effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units: a study protocol for a cluster randomised trial., Trials, 2011, 12, 1, 41, doi: 10.1186/1745-6215-12-41.

Additional files

Editorial Notes