Skip to main content
Clinical Trials/NCT01446757
NCT01446757
Completed
Not Applicable

Effectiveness of a Comprehensive CGA on Frailty in Community-dwelling Elderly People - A Randomised, Controlled Trial

Linkoeping University1 site in 1 country383 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frail Elderly
Sponsor
Linkoeping University
Enrollment
383
Locations
1
Primary Endpoint
Frailty
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.

Detailed Description

Frail older adults are at increased risk of vulnerability and serious health problems. This leads to increased suffering and higher healthcare utilization. There are major gaps in the knowledge needed to create the most favourable care model for preventing frailty and increasing health-related of life. The purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment and follow up in community-dwelling elderly people can prevent frailty, hospitalisation and adverse effects of frailty, improve health and health-related quality of life, and reduce costs, compared with usual care. In a randomized, controlled trial with 24 months of follow-up, a total of 430 older adults with multimorbidity will be randomized into two groups. The intervention group will receive Comprehensive Geriatric Assessment and follow up and the same standard health care services as the control group. The Comprehensive Geriatric Assessment and follow up will be provides through an outpatient facility that tailors care from a holistic perspective and, based on each patient's individual needs in line with the policy program that Sweden's pensioners' organizations have presented in 2010 together with the Swedish Association of Geriatric Medicine. The team includes, among other things. a. geriatricians, nurses, physiotherapists, assistance officer, dietician, pharmacist and co-operation with the dental hygienist. The primary outcome is development of frailty and hospitalization. Secondary outcomes are adverse effects of frailty, health and health-related quality of life and costs. There is a knowledge gap of how health care can identify persons with frailty and risks for frailty and how to meet their specific care needs. The study aims to fill a clinically important knowledge gap that can guide further development of future care for older people with multi-morbidity and frailty. CGA is readily transferable to clinical practice.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Linkoeping University
Responsible Party
Principal Investigator
Principal Investigator

Anne Ekdahl

Senior Consultant, geriatrician

Linkoeping University

Eligibility Criteria

Inclusion Criteria

  • Elderly 75 years and above
  • Have been hospitalized three or more times in the last 12 months
  • Have three or more diagnoses in their medical records according to the International Classification of Diseases (ICD-10)
  • Live in their own homes (not nursing home) in the municipality of Norrkoeping
  • Accept to participate in the study.
  • Exclusion criteria:
  • Fulfilling the inclusion criteria but living in a special accommodation for the elderly

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Frailty

Time Frame: 24 months

Unintentional weight loss ≥5% of the previous year. Exhaustion is assessed by two questions from the Centre for Epidemiologic Studies-Depression Scale. Low physical activity includes assessment of habitual physical activity level by using the Swedish version of the International Physical Activity Questionnaire short version (IPAQ-S).Slow walking speed is determined from the better of two attempts at usual "comfortable" walking speed over 4 m with or without a walking aid. Weakness (muscle strength) is assessed by maximal grip strength.

Hospitalisation

Time Frame: 24 months

Number of hospitalisations and in-care stays during the trial

Secondary Outcomes

  • Symptoms(0 and 24 months)
  • Quality of life of relatives(0, 12 and 24 months)
  • Cognition(0 and 24 months)
  • Health related quality of life(0 and 24 months)
  • Nutrition(0 and 24 months)
  • Activities of Daily Living(0 and 24 months)
  • Falls(0 and 24 months)
  • Depression(0 and 24 months)
  • Costs(24 months)
  • Feeling of security of the patient(0, 12 and 24 months)
  • Feeling of security of the relatives(0, 12 and 24 months)

Study Sites (1)

Loading locations...

Similar Trials