NCT00105378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

November 18, 2023

Status Verified

August 1, 2007

First QC Date

March 11, 2005

Last Update Submit

November 17, 2023

Conditions

Keywords

health care services researchfrail elderlyintermediate carepatient centered carecomprehensive health caregeriatric nursingBehavioral symptoms

Outcome Measures

Primary Outcomes (3)

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

    3 months

  • Mental health using subscale mental health MOS-20

    3 months

  • Informal caregiver burden using Zarit Burden Interview

    3 months

Secondary Outcomes (10)

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

    3 months

  • Cost effectiveness

    6 months

  • Mobility using Timed Up and Go test

    3 months

  • Overall health related Quality of life using MOS-20

    3 months

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

    3 months

  • +5 more secondary outcomes

Interventions

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, nl-6500 HB, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 16007575BACKGROUND
  • 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.

    PMID: 12008559BACKGROUND
  • 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.

MeSH Terms

Conditions

Cognition DisordersMood DisordersGait Disorders, NeurologicMalnutritionBehavioral Symptoms

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Marcel G. Olde Rikkert, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2005

First Posted

March 14, 2005

Study Start

April 1, 2003

Study Completion

July 1, 2005

Last Updated

November 18, 2023

Record last verified: 2007-08

Locations