Randomized Controlled Trial of Health Care to Elderly Patients.

This study has been completed.
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00235404
First received: October 7, 2005
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

To study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital.


Condition Intervention
Congestive Heart Failure
Angina Pectoris
Asthma
Pneumonia
Fractures
Other: Multicomponent treatment
Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Specialized Treatment and Care Intervention at a Primary Level in a Nursing Home Compared to Conventional Treatment at a Hospital: a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Number of readmissions [ Time Frame: Within 60 days ] [ Designated as safety issue: No ]
  • Number of deaths [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
  • Need of home nursing services [ Time Frame: within 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Costs [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: September 2003
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: Intermediate community hospital Other: Multicomponent treatment
Specialized care in preparing recharge to home
Active Comparator: Usual care Other: usual care
Usual recharge directly from hospital to home

Detailed Description:

Managers at St. Olavs University Hospital and the City of Trondheim local authority decided in 2001 to establish a reinforced department at a nursing home with a multicomponent approach to patient treatment.

In the study treatment at a nursing home will be compared with conventional treatment in ordinary hospital beds in medical, surgical and orthopedic departments at a hospital. Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique. Eligible participants will be hospitalized from their ordinary home and expected to return to home after treatment. When an eligible patient is identified and accepted for inclusion, randomization will be performed by the Clinical Research Department at the Faculty of Medicine.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique.

Exclusion Criteria:

  • Participating doctors at the hospital together with general practitioners shall develope exclusion criteria through Delphi technique.
  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: NCT00235404

Locations
Norway
Faculty of Medicine, The Norwegian University of Science and Technology (NTNU)
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
The Royal Norwegian Ministry of Health
Investigators
Study Chair: Roar Johnsen The Norwegian University of Science and Technology (NTNU)
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00235404     History of Changes
Other Study ID Numbers: REK 037-03
Study First Received: October 7, 2005
Last Updated: March 27, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Treatment of elderly.
Nursing home.
Rehabilitation.
Readmissions.

Additional relevant MeSH terms:
Angina Pectoris
Asthma
Fractures, Bone
Heart Failure
Pneumonia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Wounds and Injuries
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 26, 2014