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Dutch EASYcare Study

Primary Purpose

Cognition Disorders, Mood Disorder, Gait Disorder, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dutch EASYcare Study Geriatric Intermediate Care Programme
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognition Disorders focused on measuring health care services research, frail elderly, intermediate care, patient centered care, comprehensive health care, geriatric nursing, Behavioral symptoms

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale
Mental health using subscale mental health MOS-20
Informal caregiver burden using Zarit Burden Interview

Secondary Outcome Measures

Type of residence (independent, home for the elderly, nursing home)
Cost effectiveness
Mobility using Timed Up and Go test
Overall health related Quality of life using MOS-20
Well-being using Cantril Self-anchoring ladder and Dementia Quality of Life
Cognition using Mini Mental State Examination
Social functioning using Loneliness scale de Jong-Gierveld
Subjective treatment effects using Patient Enablement Instrument
Mortality
Time spent on care by informal caregiver

Full Information

First Posted
March 11, 2005
Last Updated
August 9, 2007
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00105378
Brief Title
Dutch EASYcare Study
Official Title
Effectiveness of EASYcare-Based Geriatric Intermediate Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders, Mood Disorder, Gait Disorder, Neurologic, Malnutrition
Keywords
health care services research, frail elderly, intermediate care, patient centered care, comprehensive health care, geriatric nursing, Behavioral symptoms

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Dutch EASYcare Study Geriatric Intermediate Care Programme
Primary Outcome Measure Information:
Title
Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale
Time Frame
3 months
Title
Mental health using subscale mental health MOS-20
Time Frame
3 months
Title
Informal caregiver burden using Zarit Burden Interview
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Type of residence (independent, home for the elderly, nursing home)
Time Frame
3 months
Title
Cost effectiveness
Time Frame
6 months
Title
Mobility using Timed Up and Go test
Time Frame
3 months
Title
Overall health related Quality of life using MOS-20
Time Frame
3 months
Title
Well-being using Cantril Self-anchoring ladder and Dementia Quality of Life
Time Frame
3 months
Title
Cognition using Mini Mental State Examination
Time Frame
6 months
Title
Social functioning using Loneliness scale de Jong-Gierveld
Time Frame
3 months
Title
Subjective treatment effects using Patient Enablement Instrument
Time Frame
3 months
Title
Mortality
Time Frame
within a period of maximum two years
Title
Time spent on care by informal caregiver
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel G. Olde Rikkert, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
nl-6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16007575
Citation
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.
Results Reference
background
PubMed Identifier
12008559
Citation
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.
Results Reference
background
PubMed Identifier
18375876
Citation
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.
Results Reference
derived

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Dutch EASYcare Study

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