1. A cluster randomised trial on the effectiveness of a structured education reminiscence-based programme for staff in long-stay units on the quality of life of residents with dementia. An overview of the trial protocol. 2009-2011 Funded by the Health Research Board, Ireland. Fionnuala Jordan, 1 Dr. Declan Devane, 1 Dr. Adeline Cooney, 1 Prof. Eamon O’Shea, 2 Prof. Kathy Murphy 1 Dr. Dympna Casey, 1 Edel Murphy, 1 Andrew Hunter. 1 1 School of Nursing and midwifery, National University of Ireland, Galway 2 Irish Centre for Social Gerontology, National University of Ireland, Galway 3 rd International Nursing and Midwifery Conference, School of Nursing and Midwifery, National University of Ireland, Galway. April 2011.

2. 2 Background Significant increase in the number of people with dementia in Ireland, approx. 40,000 at present to 100,000 by 2036 (O’Shea 2007). International estimates suggest approx. half of those will be cared for in a residential setting at some point during the disease process (Herbert et al., 2001). Limited information on the prevalence rates for dementia in the long-stay setting, however researchers suggest that the majority of residents are likely to have dementia (Alzheimer’s Society 2007; Cahill et al., 2009). Systematic reviews indicate psychosocial interventions have the potential to improve the quality of life of people with dementia and those who care for them (Livingston et al., 2005; Woods 2002; Brodaty et al., 2003). Reminiscence is a popular psychosocial intervention in dementia care and is enjoyed by both staff and participants (Woods et al., 2005). However, Little is know about it’s effectiveness as a care intervention for people with dementia (Gibson 2004; Woods et al., 2005; Moos & Bjorn 2006). Most recent Cochrane review (2005) indicated some evidence of an improvement in cognition/general behaviour/caregiver strain. However, included studies were small and of relatively poor quality, resulting in inconclusive evidence to support it’s effectiveness. Hence more rigorous evaluation required, the authors recommended that the type of reminiscence and it ’ s aims are clearly defined.

3. Study intervention The type of reminiscence and its aims are clearly defined and informed by theoretical concepts Standardisation of the delivery of the intervention: SERPS is facilitated by a core group of experienced educators and is delivered over three days in all sites Adherence to the study intervention: The research team provide telephone support to staff participants during the duration of the study, as well as conducting one support visit to each unit. Participating staff are provided with recording sheets and document all reminiscence sessions conducted with each resident Participating staff also complete a life history with each of their residents in order to provide a foundation for the reminiscence sessions.

4. 4 The DARES Study: DementiA education programme incorporating REminiscence for Staff Aim of this presentation: To give an overview of the DARES Study protocol. The primary aim of the DARES study is to evaluate the effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units. The study has three main objectives: To develop a comprehensive structured education reminiscence-based programme for staff (SERPS) that is specifically orientated toward embedding reminiscence within the resident ’ s care plan. To evaluate the effectiveness of the SERPS within the context of a cluster randomised trial. To understand participants ’ (staff and people with dementia) perceptions of the SERPS, its impact on their lives and experience of care.

5. Outcomes Primary outcome Quality of Life-Alzheimer’s Disease (QOL-AD) scale- both care recipient and caregiver versions (Logsdon et al., 1999) Secondary outcomes Residents levels of agitation measured by the Cohen Mansfield Agitation Inventory (CMAI) scale (Cohen & Billing 1986) Residents levels of depression measured by the Cornell Scale for Depression in Dementia (CSDD) scale (Alexopolous et al., 1988) Staff burden of care measured by the Modified Zarit Burden Interview scale (Zarit et al., 1980)

6. 6 Methods/Design The DARES study is a two-group, single blind cluster randomised trial conducted in public and private long stay residential settings in Ireland. Randomisation to control and intervention is at the level of the long-stay residential unit (see next slide). Care staff within long-stay residential unit allocated to the intervention arm receive the structured education reminiscence-based programme and they implement reminiscence with eligible consenting residents. Care staff allocated to the control group receive no training and residents receive usual care. Usual care will be clearly defined through interviews with managers of the long-stay units or staff nurses, and through documentary analysis of the residents care plan. Blinded outcome assessments are undertaken by trained research nurses for both the control and experimental group at baseline (T1), following consent and prior to randomisation and cluster allocation and again at 18-22 weeks post randomisation (T2). Comparisons will be made to examine if differences exist, and to what extent, between control and experimental groups. Ethical approval granted by the Research Ethics Committee of the National University of Ireland, Galway and appropriate county/hospital-based ethic committees responsible for participating public long-stay facilities. Analysis- Focus is on the long-stay unit with the resident as the unit of analysis. Analysis is by intention to treat, with all available data included.

7. Randomisation process Randomisation is 1:1 ratio and is stratified by public and private units to ensure an appropriate representation of public and private units; a ratio of one third public and 2 thirds private reflects the overall distribution of beds in the region. The random allocation sequence is generated using a computer generated random number list (the Mersenne Twister, Stat Direct). Concealment of the group allocation is achieved by giving responsibility for sequence generation and group allocation to a researcher with statistical expertise and who is independent of the study and its investigators. Details outlined in the protocol document.

8. Sample size Sample size was estimated using methods for standard trials that are randomised at the level of the individual (Devane et al., 2004) with adjustment for clustering as recommended by Donner et al (2004). Based on a mean QOL–AD score of 32.5 for people with dementia in residential care homes (Hoe et al., 2009) and an Intra-class correlation coefficient (ICC) value of 0.1 identified from pilot work on reminiscence groups for people with dementia for the REMCARE Trial (Woods et al., 2009), a total of 18 residential units are required, each containing 17 people with dementia (n=306), to detect a 4 point difference in mean QOL-AD scores between control and experimental groups, for power of at least 80% with alpha levels of 0.05. This calculation allows for a loss to follow-up of 20% of residents and up to 3 residential units. ICC values lower than 0.1 would increase the power of the study.

9. 9 Study Sites: Long-stay units (Clusters) Public and private long-stay units across the Western half of the Republic of Ireland who meet the eligibility criteria were invited to participate. Eligibility criteria for long- stay care units Have 17 residents with dementia who agree directly or through proxy to participate in the study.

10. 10 Participants: Residents with dementia Eligibility criteria for residents with dementia Given the reality that formal diagnosis of dementia in residential care in Ireland is rare, diagnosis of dementia in residents was determined in any one, or more, of the following ways: I.A formal diagnosis of dementia determined by the DSM-1V (APA 1995) or ICD-10 (WHO 1992) criteria for dementia II.Any other diagnosis of dementia by a medical clinician III.Resident is on anti-Alzheimer ’ s medications, including Aricept (Donepezil), Ebixa (Memantine) and Exelon (rivastigmine) IV.Nurses ’ judgement and/or nursing records advise that the person has dementia.

11. 11 Residents are excluded from the study they have any of the following: A sensory impairment that, in the judgement of the appropriate nursing staff, impairs their ability to participate. An acute physical illness that, in the judgement of the appropriate nursing staff, impairs their ability to participate.

12. Consenting process for residents Director of Nursing/Nurse in Charge/their nominee identify all residents fulfilling the trial inclusion criteria Care staff introduce research nurse (RN) to each potential participant and spends time building rapport and explores whether the resident is interested in participating, if not interested the RN will not pursue any further If interested, the RN provides written information about the study to the resident and their relevant next of kin Where a potential participant is willing to engage in the trial, express an understanding of its purpose, voluntary nature, choice to participate. The RN finalises the consent process directly with the resident Not possible to gain consent directly: RA seeks consent by proxy from the residents next-of-kin Assent is assessed throughout the study in both instances. Where consent is not forthcoming at any stage, the resident is withdrawn from the study without consequence.

13. 13 Participants: Staff Ten consenting staff per unit, consisting of 5 nurses paired with 5 healthcare assistants (5 dyads). Each nurse and health care assistant participating in the study will usually have worked within the care setting for at least three months and are likely to be working there for the duration of the Trial. Each participating dyad are allocated 3-4 participating residents with dementia, with whom they implement reminiscence for the duration of the study.

14. 14 Current status of study A pilot study has been conducted with two residential units. This pilot was be used to identify problems with the research design/processes; refine data collection and analysis; assess adequacy of data sources; examine selection and enrolment processes; test instruments; and assess the resident and staff perspectives on participating. We will not include data from the pilot period in the main analyses of the trial. All research nurses underwent a two-day training programme prior to baseline data collection and receive on-going support from the research team Baseline data collection is completed in all 18 long-stay units. Data is coded, checked, cleaned, entered into SPSS and verified The structured educational programme is presently being delivered in all intervention sites Post data collection is completed in 13 sites and is underway in remaining sites Data analysis is estimated to begin in early summer 2011 Study is due to be completed by end of 2011

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