Dutch EASYcare Study

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00105378
First received: March 11, 2005
Last updated: August 9, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention
Cognition Disorders
Mood Disorder
Gait Disorder, Neurologic
Malnutrition
Behavioral: Dutch EASYcare Study Geriatric Intermediate Care Programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of EASYcare-Based Geriatric Intermediate Care

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Functional performance (independent) activities of daily living measured using Groningen Activity Restriction Scale [ Time Frame: 3 months ]
  • Mental health using subscale mental health MOS-20 [ Time Frame: 3 months ]
  • Informal caregiver burden using Zarit Burden Interview [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Type of residence (independent, home for the elderly, nursing home) [ Time Frame: 3 months ]
  • Cost effectiveness [ Time Frame: 6 months ]
  • Mobility using Timed Up and Go test [ Time Frame: 3 months ]
  • Overall health related Quality of life using MOS-20 [ Time Frame: 3 months ]
  • Well-being using Cantril Self-anchoring ladder and Dementia Quality of Life [ Time Frame: 3 months ]
  • Cognition using Mini Mental State Examination [ Time Frame: 6 months ]
  • Social functioning using Loneliness scale de Jong-Gierveld [ Time Frame: 3 months ]
  • Subjective treatment effects using Patient Enablement Instrument [ Time Frame: 3 months ]
  • Mortality [ Time Frame: within a period of maximum two years ]
  • Time spent on care by informal caregiver [ Time Frame: 3 months ]

Enrollment: 155
Study Start Date: April 2003
Study Completion Date: July 2005
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.
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105378

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, nl-6500 HB
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Marcel G. Olde Rikkert, MD PhD Radboud University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00105378     History of Changes
Other Study ID Numbers: GEREASYEFF014-91-055, 014-91-055
Study First Received: March 11, 2005
Last Updated: August 9, 2007
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Radboud University:
health care services research
frail elderly
intermediate care
patient centered care
comprehensive health care
geriatric nursing
Behavioral symptoms

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Mood Disorders
Cognition Disorders
Disease
Nervous System Diseases
Gait Disorders, Neurologic
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014