Quality of LifeNCT01925105
Comprehensive Geriatric Assessment - Can it Improve Quality of Life
A study testing Experimental: Optimization of treatment in people with Quality of Life, run by Örebro County Council at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Experimental: Optimization of treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Psychosis
- Not understand the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Quality of Life
- Being tested
- Experimental: Optimization of treatment
- Keywords
- Polypharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Optimization of treatmentOther
Optimization of treatment of diseases and symptoms
| Study group | Role | What they receive |
|---|---|---|
| Optimization of treatment | Experimental | Optimization of treatment of diseases and symptoms Receives: Other: Experimental: Optimization of treatment |
| Control | Placebo comparator | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retained or increased quality of life of at least 20% measured by EQ-5D (EuroQOL) after 1 year from baseline.
Measured: 1 year from baseline
Secondary outcomes (1)
Readmission to hospital
Measured: 1 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anna Engfeldt, Örebro County Council
- Investigators
- Peter Engfeldt, Professor, Study chair, Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925105
- Sponsor's protocol ID
- AFC-162
- Status last verified
- Sep 2015
- First submitted
- 13 Aug 2013
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment - Can it Improve Quality of Life
- ClinicalTrials.gov ID
- NCT01925105
- Acronym / sponsor ID
- AFC-162
- Conditions
- Quality of Life
- Keywords
- Polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Örebro County CouncilOther government
- Study start
- Aug 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimization of treatment | Experimental | Other: Experimental: Optimization of treatmentOptimization of treatment of diseases and symptoms |
| Control | Placebo comparator | –Treatment as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Psychosis
- Not understand the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Optimization of treatmentOptimization of treatment of diseases and symptoms | Other | Optimization of treatment |
Primary outcome
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 secondary outcome
Readmission to hospital
Time frame: 1 year from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Engfeldt, Professor study chair
Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Optimization of treatment in people with Quality of Life, run by Örebro County Council at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.