Condition category
Mental and Behavioural Disorders
Date applied
30/06/2009
Date assigned
27/08/2009
Last edited
27/08/2009
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

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 measures

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

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

http://www.cvz.nl/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes