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Cognition DisordersNCT00105378

Dutch EASYcare Study

A study testing Dutch EASYcare Study Geriatric Intermediate Care Programme in people with Cognition Disorders and Mood Disorder, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to study the effects of nursing home visits in independently living elderly people on their functional performance and health-related quality of life. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Dutch EASYcare Study Geriatric Intermediate Care Programme
How many people
155 participants
Where
1 siteNetherlands
Study dates
Apr 2003to Jul 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 70 years of age and over
  • The patient lives independently or in a home for the aged
  • The patient has a health problem that was recently presented to the GP by the patient or informal caregiver
  • The request for help is related to the following problem fields: cognitive disorders, behavioral and psychological symptoms of dementia, mood disorders, mobility disorders and falling, or malnutrition
  • The patient/informal caregiver and GP have determined a goal they want to achieve
  • Fulfill one or more of these criteria: MMSE (Mini Mental State Examination) equal to or less than 26, GARS (Groningen Activity Restriction Scale) equal to or greater than 25 or MOS-20/subscale mental health equal to or less than 75

Who cannot join

  • The problem or request for help has an acute nature, urging for action (medical or otherwise) within less than one week
  • The problem or request for help is merely a medical diagnostic issue, urging for action only physicians (GP or specialist) can offer
  • MMSE < 20 or proved moderate to severe dementia (Clinical Dementia Rating scale [CDR] > 1, 0) and no informal caregiver (no informal caregiver is defined as: no informal caregiver who meets the patient for at least once a week on average)
  • The patient receives other forms of intermediate care or health care from a social worker or community-based geriatrician
  • The patient is already on the waiting list for a nursing home because of the problem the patient is presented with in our study
  • Predicted prognosis < 6 months because of terminal illness

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Centre

    Nijmegen, Gelderland, nl-6500 HB

Other trials in Netherlands

About this study

Official title: Effectiveness of EASYcare-based Geriatric Intermediate Care

The purpose of this study is to study the effects of nursing home visits in independently living elderly people on their functional performance and health-related quality of life. The general practitioner (GP) can refer elderly people to this intervention model after identification of a problem in cognition, mood, behavior, mobility, or nutrition. A specialist geriatric nurse visits the patients at home up to six times and coaches the patient in cooperation with the GP and geriatrician.

Read the detailed description

General practitioners (GPs) in the Western world have to anticipate the increasing age and health care demands of their patients. A considerable proportion of those older patients have reduced functional status and quality of life, which may affect their feelings of autonomy and ability to live independently. Even with considerable disability, most patients prefer to stay at home. Because of their complex clinical presentations and needs, these patients require a special approach to their evaluation and care.

Intermediate care is a possible answer to these changing demands, although the efficacy of these programs is a subject of vivid debate.

With the Dutch Geriatric Intermediate Care Programme (DGIP) we developed an Intermediate Care model to study efficacy aspects of problem based intermediate care. DGIP is an intermediate care program in which the GP refers elderly patients with a problem in cognition, mood, behavior, mobility, and nutrition. A geriatric specialist nurse applies a guideline based intervention in a maximum of six visits during a maximum of three months. The nurse starts the intervention with the application of the EASYcare instrument for geriatric screening. The EASYcare instrument assesses (instrumental) activities of daily life, cognition, mood, and includes a goal setting item. During the intervention the nurse regularly consults the referring GP and a geriatrician.

Objectives

  • To determine the effects of the Dutch EASYcare Study Geriatric Intermediate care Programme compared to regular medical care in improving health related quality of life in independently living elderly persons and their informal caregivers who contact the GP with one of a variety of geriatric problems.
  • To determine the costs of the Dutch EASYcare Study Geriatric Intermediate care Programme.
Being tested
Dutch EASYcare Study Geriatric Intermediate Care Programme
Keywords
health care services research, frail elderly, intermediate care, patient centered care, comprehensive health care, geriatric nursing, Behavioral symptoms
Medical subject headings
Cognition Disorders, Mood Disorders, Gait Disorders, Neurologic, Malnutrition, Behavioral Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dutch EASYcare Study Geriatric Intermediate Care ProgrammeBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale

    Measured: 3 months

  2. Mental health using subscale mental health MOS-20

    Measured: 3 months

  3. Informal caregiver burden using Zarit Burden Interview

    Measured: 3 months

Secondary outcomes (10)

  1. Type of residence (independent, home for the elderly, nursing home)

    Measured: 3 months

  2. Cost effectiveness

    Measured: 6 months

  3. Mobility using Timed Up and Go test

    Measured: 3 months

  4. Overall health related Quality of life using MOS-20

    Measured: 3 months

  5. Well-being using Cantril Self-anchoring ladder and Dementia Quality of Life

    Measured: 3 months

  6. Cognition using Mini Mental State Examination

    Measured: 6 months

  7. Social functioning using Loneliness scale de Jong-Gierveld

    Measured: 3 months

  8. Subjective treatment effects using Patient Enablement Instrument

    Measured: 3 months

  9. Mortality

    Measured: within a period of maximum two years

  10. Time spent on care by informal caregiver

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2005 (estimated)
  2. Study startApr 2003
  3. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00105378
Sponsor's protocol ID
GEREASYEFF014-91-055
Other IDs
014-91-055
Status last verified
Aug 2007
First submitted
11 Mar 2005
Last updated
18 Nov 2023
Results posted
No

Publications

  • Borm GF, Melis RJ, Teerenstra S, Peer PG. Pseudo cluster randomization: a treatment allocation method to minimize contamination and selection bias. Stat Med. 2005 Dec 15;24(23):3535-47. doi: 10.1002/sim.2200.

    PubMed 16007575

  • Richardson J. The Easy-Care assessment system and its appropriateness for older people. Nurs Older People. 2001 Oct;13(7):17-9. doi: 10.7748/nop.13.7.17.s15. No abstract available.

    PubMed 12008559

  • Melis RJ, Adang E, Teerenstra S, van Eijken MI, Wimo A, van Achterberg T, van de Lisdonk EH, Rikkert MG. Cost-effectiveness of a multidisciplinary intervention model for community-dwelling frail older people. J Gerontol A Biol Sci Med Sci. 2008 Mar;63(3):275-82. doi: 10.1093/gerona/63.3.275.

    PubMed 18375876

Questions about this trial

What is this clinical trial studying?

A study testing Dutch EASYcare Study Geriatric Intermediate Care Programme in people with Cognition Disorders and Mood Disorder, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105378, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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