Contact information
Type
Scientific
Primary contact
Dr Rose-Marie Droes
ORCID ID
Contact details
Valeriusplein 9
Amsterdam
1075 BG
Netherlands
+31 (0)20 788 5454
r.droes@ggzingeest.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Medical Ethical Commission of the VU University Medical Centre approved in 1995
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/04/1996
Overall trial end date
31/03/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
146 people with dementia and 125 professional carers
Participant 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
Recruitment start date
01/04/1996
Recruitment end date
31/03/1999
Locations
Countries of recruitment
Netherlands
Trial participating centre
Valeriusplein 9
Amsterdam
1075 BG
Netherlands
Sponsor information
Organisation
The Dutch Health Care Insurance Board (CVZ) (Netherlands)
Sponsor details
Eekholt 4
Diemen
1112 XH
Netherlands
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Dutch Health Care Insurance Board (CVZ) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2001 family member opinion results in http://www.ncbi.nlm.nih.gov/pubmed/11529975
2. 2005 RCT results in http://www.ncbi.nlm.nih.gov/pubmed/15799079
Publication citations
-
Family member opinion results
Finnema E, de Lange J, Dröes RM, Ribbe M, van Tilburg W, The quality of nursing home care: do the opinions of family members change after implementation of emotion-oriented care?, J Adv Nurs, 2001, 35, 5, 728-740.
-
RCT results
Finnema E, Dröes RM, Ettema T, Ooms M, Adèr H, Ribbe M, van Tilburg W, The effect of integrated emotion-oriented care versus usual care on elderly persons with dementia in the nursing home and on nursing assistants: a randomized clinical trial., Int J Geriatr Psychiatry, 2005, 20, 4, 330-343, doi: 10.1002/gps.1286.