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Mood Disorder

 




Clinical Trial: Dutch EASYcare Study

This study is no longer recruiting patients.

Sponsored by: Radboud University
Information provided by: Radboud University

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 Treatment or Intervention
Cognition Disorders
Mood Disorder
Gait Disorder, Neurologic
Malnutrition
 Behavior: Dutch EASYcare Study Geriatric Intermediate Care Programme

MedlinePlus related topics:  Mental Health;   Neurologic Diseases;   Nutrition

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Effectiveness of EASYcare-based Geriatric Intermediate Care

Further Study Details: 
Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  154

Study start: April 2003;  Study completion: February 2006
Last follow-up: July 2005;  Data entry closure: August 2005

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 above,  Genders Eligible for Study:  Both

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

Location Information


Netherlands, Gelderland
      Radboud University Nijmegen Medical Centre, Nijmegen,  Gelderland,  nl-6500 HB,  Netherlands

Study chairs or principal investigators

Marcel G. Olde Rikkert, MD PhD,  Principal Investigator,  Radboud University   

More Information

Publications

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

Study ID Numbers:  GEREASYEFF014-91-055; 014-91-055
Record last reviewed:  March 2005
Last Updated:  March 14, 2005
Record first received:  March 11, 2005
ClinicalTrials.gov Identifier:  NCT00105378
Health Authority: Netherlands: Independent Ethics Committee (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: October 3, 2005
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