Evaluation of emotion-oriented care versus usual care for elderly persons with dementia in the nursing home

ISRCTN	ISRCTN15609358
DOI	https://doi.org/10.1186/ISRCTN15609358
Secondary identifying numbers	N/A

Submission date: 30/06/2009
Registration date: 27/08/2009
Last edited: 27/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rose-Marie Droes
Scientific

Valeriusplein 9
Amsterdam
1075 BG
Netherlands

Phone	+31 (0)20 788 5454
Email	r.droes@ggzingeest.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Integrated emotion-oriented care versus usual care for elderly persons with dementia in the nursing home: a clinical experimental study into the effects and costs
Study objectives	1. Integrated emotion-oriented care in nursing homes has as compared to usual care more positive effect on: 1.1. The adaptation of demented elderly to their disabilities and to the nursing home 1.2. The general health of the nursing assistants 1.3. The satisfaction of relatives of residents with dementia 2. Integrated emoion-oriented care is more cost-effective than usual care
Ethics approval(s)	Medical Ethical Commission of the VU University Medical Centre approved in 1995
Health condition(s) or problem(s) studied	Dementia, psychogeriatrics
Intervention	Intervention: Dutch Model Care plan and integrated emotion-oriented care, partly based on the validation approach, partly based on elements of other psychosocial care strategies/approaches in dementia care such as the reality orientation approach, reminiscence and sensory stimulation. The starting point of the application of the integrated emotion-oriented care strategy/approach are the individual emotional and social needs of the residents as well as their physical and mental (dis)abilities. Control: Dutch Model Care plan only. We investigated if professional caregivers (most nurses and nurse assitants) applied the emotion-oriented care method as trained. The caregivers (n = 61) in the experimental wards were trained to work according to the principles of the Dutch Model Care plan as well as an integrated emotion-oriented care for people with dementia, while the caregivers (n = 63) in the control wards were trained in working according to the Dutch Model Care plan only. In the pre-experimental period the caregivers of both the experimental group and the control group received 6 days of training (course and supervision/training on the job) on the Dutch Model Care plan to make the groups comparable on basic care quality. During the intervention period the training on the job and supervision on how to work according to the Dutch Model Care plan proceeded in both research arms, while in the experimental group a selection of caregivers were trained (10 days) as consultants in integrated emotion-oriented care and the other caregivers received a basic course in integrated emotion-oriented care (2 days; n = 32 caregivers per ward of 30 residents) and some of them also an advanced course (7 days; one out of 4 caregivers who passed the basic course). The pre-experimental period was 6 months, the intervention period (actual implementation of integrated emotion-oriented care) was 7 months. Pre- and post-tests measurements in the experimental group took place directly before the start of the courses in emotion-oriented care and after 7 months, and in the control group after the training in the Dutch Model Care plan and 7 months later. At 7 months in both arms a retrospective baseline measurement was executed as well. Qualitative observation data were gathered by participant observation during 9 days at 8 of the 15 ward units at baseline and after 7 months.
Intervention type	Other
Primary outcome measure	1. Behaviour and mood problems as symptoms of difficulties with the cognitive, emotional and social adaptation to the consequences of the disease and nursing home admittance 2. Positive behaviour, affect and institutionalisation All measurements of this implementation effectiveness study took place at baseline and after 7 months.
Secondary outcome measures	General health of professional caregivers: 1. Stress experience 2. Stress reactions 3. Illness 4. Sense of competence All measurements of this implementation effectiveness study took place at baseline and after 7 months.
Overall study start date	01/04/1996
Completion date	31/03/1999

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	146 people with dementia and 125 professional carers
Key inclusion criteria	1. Patients: 1.1. Persons older than 65 years of age, either sex 1.2. Probable diagnosis of dementia of the alzheimer-type (DAT), mixed diagnosis of DAT and vascular dementia, amnestic syndrome and dementia syndrome not otherwise specified 1.3. In need of assistance or care 1.4. Living in nursing homes for at least one month before the start of the baseline measurement 2. Professional caregivers in the experimental group: 2.1. Certified nursing assistants that followed the course Validation-worker 2.2. First responsible nurse assistants 3. Professional caregivers in the control group: 3.1. Nurse assistants that were matched with the experimental group on education, age and work experience 3.2. Did not participate in any course of Validation-worker 4. Relatives: frequence of visiting the resident with dementia at least ones a month
Key exclusion criteria	1. Patients: refusal to participate in the study 2. People who did not fullfil the inclusion criteria 3. People with severe physical disabilities (such as total blindness or muteness), that made adequate data collection for the effect study impossible 4. Professional caregivers: 4.1. Did not fulfil the inclusion criteria 4.2. Were not prepared to participate in the study
Date of first enrolment	01/04/1996
Date of final enrolment	31/03/1999

Locations

Countries of recruitment

Netherlands

Study participating centre

Valeriusplein 9

Amsterdam
1075 BG
Netherlands

Sponsor information

The Dutch Health Care Insurance Board (CVZ) (Netherlands)
Government

Eekholt 4
Diemen
1112 XH
Netherlands

Website	http://www.cvz.nl/

Funders

Funder type

Government

The Dutch Health Care Insurance Board (CVZ) (Netherlands)

No information available

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?
Results article	family member opinion results	01/09/2001		Yes	No
Results article	RCT results	01/04/2005		Yes	No