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Randomized Controlled Trial of Health Care to Elderly Patients.

Primary Purpose

Congestive Heart Failure, Angina Pectoris, Asthma

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multicomponent treatment
usual care
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Treatment of elderly., Nursing home., Rehabilitation., Readmissions.

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, The Norwegian University of Science and Technology (NTNU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermediate community hospital

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Number of readmissions
Number of deaths
Need of home nursing services

Secondary Outcome Measures

Costs

Full Information

First Posted
October 7, 2005
Last Updated
July 28, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF
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1. Study Identification

Unique Protocol Identification Number
NCT00235404
Brief Title
Randomized Controlled Trial of Health Care to Elderly Patients.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Angina Pectoris, Asthma, Pneumonia, Fractures
Keywords
Treatment of elderly., Nursing home., Rehabilitation., Readmissions.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermediate community hospital
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Multicomponent treatment
Intervention Description
Specialized care in preparing recharge to home
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
Usual recharge directly from hospital to home
Primary Outcome Measure Information:
Title
Number of readmissions
Time Frame
Within 60 days
Title
Number of deaths
Time Frame
Within 12 months
Title
Need of home nursing services
Time Frame
within 12 months
Secondary Outcome Measure Information:
Title
Costs
Time Frame
Within 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roar Johnsen
Organizational Affiliation
The Norwegian University of Science and Technology (NTNU)
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, The Norwegian University of Science and Technology (NTNU)
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17475006
Citation
Garasen H, Windspoll R, Johnsen R. Intermediate care at a community hospital as an alternative to prolonged general hospital care for elderly patients: a randomised controlled trial. BMC Public Health. 2007 May 2;7:68. doi: 10.1186/1471-2458-7-68.
Results Reference
result
PubMed Identifier
18264150
Citation
Garasen H, Magnussen J, Windspoll R, Johnsen R. [Elderly patients in hospital or in an intermediate nursing home department--cost analysis]. Tidsskr Nor Laegeforen. 2008 Jan 31;128(3):283-5. Norwegian.
Results Reference
result
PubMed Identifier
18519285
Citation
Garasen H, Windspoll R, Johnsen R. Long-term patients' outcomes after intermediate care at a community hospital for elderly patients: 12-month follow-up of a randomized controlled trial. Scand J Public Health. 2008 Mar;36(2):197-204. doi: 10.1177/1403494808089685.
Results Reference
result

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Randomized Controlled Trial of Health Care to Elderly Patients.

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