Dutch EASYcare Study

November 17, 2023 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Marcel G. Olde Rikkert, MD PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

March 11, 2005

First Submitted That Met QC Criteria

March 11, 2005

First Posted (Estimated)

March 14, 2005

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEREASYEFF014-91-055
  • 014-91-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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