Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
21/12/2011
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 Danielle Jansen

ORCID ID

Contact details

Institute for Research in Extramural Medicine
Department of General Practice
Vrije University Medical Centre
Van der Boechorststraat 7
Amsterdam
1081 HV
Netherlands
+31 (0)20 4441716
d.jansen@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw-number: 2200.0114; NTR66

Study information

Scientific title

Acronym

PIKOM (in Dutch: Preventive Intervention among cognitively frail elderly and their care giver)

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, single blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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)

Secondary outcome measures

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

Overall trial start date

15/07/2002

Overall trial end date

15/07/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Assistance by an outpatient geriatric team for cognitive problems
2. Terminal illness
3. Participation in other research projects and institutionalisation

Recruitment start date

15/07/2002

Recruitment end date

15/07/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Institute for Research in Extramural Medicine
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The 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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21356537

Publication citations

  1. Results

    Jansen AP, van Hout HP, Nijpels G, Rijmen F, Dröes RM, Pot AM, Schellevis FG, Stalman WA, van Marwijk HW, Effectiveness of case management among older adults with early symptoms of dementia and their primary informal caregivers: a randomized clinical trial., Int J Nurs Stud, 2011, 48, 8, 933-943, doi: 10.1016/j.ijnurstu.2011.02.004.

Additional files

Editorial Notes