This trial is active, not recruiting.

Condition quality of life
Treatment experimental: optimization of treatment
Sponsor Örebro County Council
Start date August 2013
End date April 2016
Trial size 220 participants
Trial identifier NCT01925105, AFC-162


Like most developed countries the population of Sweden is getting older and consequently the number of individuals with chronic diseases will be an increasing challenge for its healthcare system. To improve care of the frail elderly, wards with a coordinated multidisciplinary team and multidisciplinary mobile teams were established several years ago. Treatment and follow up is planned in accordance to the patients' medical, psychological and functional capabilities (Comprehensive Geriatric Assessment = CGA). There are to our knowledge only few studies concerning CGA applicable to Swedish conditions. We plan to conduct a Swedish study that evaluates if care and treatment with a modified CGA-model in an outpatient setting can improve quality of life for frail older people.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Optimization of treatment of diseases and symptoms
experimental: optimization of treatment
Optimization of treatment of diseases and symptoms
(Placebo Comparator)
Treatment as usual

Primary Outcomes

Retained or increased quality of life of at least 20% measured by EQ-5D (EuroQOL) after 1 year from baseline.
time frame: 1 year from baseline

Secondary Outcomes

Readmission to hospital
time frame: 1 year from baseline

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - Age ≥65 years - Live in own home - Reason to believe that the health condition is not optimal or could be optimized - Meet at least 2/6 of the following criteria: cognitive impairment, general tiredness or dyspnea, have fallen often/afraid to fall, need help with activities of daily living, hospital care ≥3 times within the last 12 months, care problems at home Exclusion Criteria: - Psychosis - Not understand the Swedish language

Additional Information

Official title Comprehensive Geriatric Assessment - Can it Improve Quality of Life
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Örebro County Council.