- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925105
Comprehensive Geriatric Assessment - Can it Improve Quality of Life
September 14, 2015 updated by: Anna Engfeldt, Örebro County Council
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Örebro, Sweden, 70116
- Örebro County Council
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Optimization of treatment
Optimization of treatment of diseases and symptoms
|
Optimization of treatment of diseases and symptoms
|
Placebo Comparator: Control
Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Readmission to hospital
Time Frame: 1 year from baseline
|
1 year from baseline
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The quality of drug treatment
Time Frame: 1 year from baseline
|
1 year from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Peter Engfeldt, Professor, Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
August 13, 2013
First Submitted That Met QC Criteria
August 15, 2013
First Posted (Estimate)
August 19, 2013
Study Record Updates
Last Update Posted (Estimate)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 14, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AFC-162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
Clinical Trials on Experimental: Optimization of treatment
-
University Hospital HeidelbergRecruiting
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCWithdrawn
-
Istituto Auxologico ItalianoEuropean Society of HypertensionRecruitingMasked HypertensionItaly, Venezuela
-
Duke UniversityStanford University; Department for International Development, United Kingdom; International Initiative for Impact Evaluation and other collaboratorsCompletedSepsis | Obstetric Labor Complications | Pre-eclampsia | Neonatal Mortality | Post-partum HemorrhageIndia
-
Riphah International UniversityRecruitingAutism Spectrum DisorderPakistan
-
IRCCS National Neurological Institute "C. Mondino...Unknown
-
Riphah International UniversityRecruitingArthropathy of KneePakistan
-
Fondation Ophtalmologique Adolphe de RothschildTerminatedOcclusion or Malformation of a Cerebral VesselFrance
-
Fundacion para la Investigacion Biomedica del Hospital...Recruiting
-
Reistone Biopharma Company LimitedCompletedAtopic DermatitisChina, Canada