Randomized Controlled Trial of Health Care to Elderly Patients.

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00235404
• Collaborator: Helse Nord-Trøndelag HF (Other)
• Enrollment: 142
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 7.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure; Angina Pectoris; Asthma; Pneumonia; Fractures	Other: Multicomponent treatment; Other: usual care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Sep 1, 2003
• Actual Study Completion Date: May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Number of readmissions [Within 60 days]

2. Number of deaths [Within 12 months]

3. Need of home nursing services [within 12 months]

Secondary Outcome Measures

1. Costs [Within 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, The Norwegian University of Science and Technology (NTNU)	Trondheim		Norway	7489

Sponsors and Collaborators

• Norwegian University of Science and Technology
• Helse Nord-Trøndelag HF

Investigators

• Study Chair: Roar Johnsen, The Norwegian University of Science and Technology (NTNU)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT00235404
• Other Study ID Numbers: REK 037-03
• First Posted: Oct 10, 2005
• Last Update Posted: Jul 29, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Norwegian University of Science and Technology: Treatment of elderly.; Nursing home.; Rehabilitation.; Readmissions.
• Additional relevant MeSH terms: Heart Failure; Angina Pectoris

Study Results

No Results Posted as of Jul 29, 2016