Effectiveness and cost-effectiveness of a care-programme by district nurses among elderly with dementia symptoms and their primary informal caregiver

ISRCTN	ISRCTN83135728
DOI	https://doi.org/10.1186/ISRCTN83135728
Protocol serial number	ZonMw-number: 2200.0114; NTR66
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 21/12/2011

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 Danielle Jansen
Scientific

Institute for Research in Extramural Medicine
Department of General Practice
Vrije University Medical Centre
Van der Boechorststraat 7
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 4441716
Email	d.jansen@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, single blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PIKOM (in Dutch: Preventive Intervention among cognitively frail elderly and their care giver)
Study objectives	Caregivers' sense of competence will improve significantly more in participants of the intervention group compared to the participants in the usual care group.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Dementia, Dementia symptoms
Intervention	1. Usual care 2. Care programme by district nurses Measurements are at baseline and after 6 and 12 months. Randomization takes place after baseline. The random order is established by an independent person using random number tables.
Intervention type	Other
Primary outcome measure(s)	1. Sense of mastery over the caregiver task as measured with the Sense of Competence Questionnaire (SCQ) 2. Quality of life by means of the MOS 36-item short-form health survey (SF-36) 3. Psychological well-being as determined with the Center for Epidemiologic Studies Depression Scale (CES-D)
Key secondary outcome measure(s)	1. Days until institutionalisation of the patient as checked with the GPs 2. Quality of life of the patient as measured with the Dementia Quality of Life Instrument (DQOL) 3. Days until death of the patient as checked with the GPs 4. Hospital days of the patient by means of cost diaries
Completion date	15/07/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Elderly are eligible for trial entry if they: 1.1. Are 65 years or over 1.2. Live outside of institutional settings 1.3. Suffer from dementia symptoms* 1.4. Have a primary informal caregiver 2. Both caregiver and patient should have a good command of the Dutch language *Patients with dementia symptoms are persons with multiple cognitive impairments (i.e. memory impairments, aphasia, apraxia, agnosia, and impairment in executive functioning). It is assumed that these dementia symptoms lead to significant limitations in social functioning, progressive decline in general functioning.
Key exclusion criteria	1. Assistance by an outpatient geriatric team for cognitive problems 2. Terminal illness 3. Participation in other research projects and institutionalisation
Date of first enrolment	15/07/2002
Date of final enrolment	15/07/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Institute for Research in Extramural Medicine

Amsterdam
1081 HV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No