Drug Usage Clinical Trial
— COOPOfficial title:
Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Verified date | January 2018 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.
Status | Completed |
Enrollment | 192 |
Est. completion date | September 22, 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - The patient must be on the list of one of the family physicians participating in the study - Home dwelling (not permanently institutionalised) - Medications administered by the home nursing service - Polypharmacy defined as the use of at least seven different systemic medications taken regularly - Informed consent by the patient or a close relative Exclusion Criteria: - Patient or relative denies inclusion - The family physician does not want the particular patient to participate - Moderate/severe dementia (Clinical Dementia Rating Scale score > 1) and contact with the closest proxy less than once every other week. - The patient does not speak/understand Norwegian - Expected to become permanently institutionalised within six months - Life expectancy < six months |
Country | Name | City | State |
---|---|---|---|
Norway | Dept. of Geriatric Medicine, Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | The Research Council of Norway, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health-related quality of life as measured with 15D | 16 weeks | ||
Secondary | Short Physical Performance Battery (SPPB) | 16 weeks | ||
Secondary | Short Physical Performance Battery (SPPB) | 24 weeks | ||
Secondary | Gait speed | 16 weeks | ||
Secondary | Gait speed | 24 weeks | ||
Secondary | Hand grip strength | 16 weeks | ||
Secondary | Hand grip strength | 24 weeks | ||
Secondary | Functional Independence Measure (FIM) | 16 weeks | ||
Secondary | Functional Independence Measure (FIM) | 24 weeks | ||
Secondary | Trail making test A and B | 16 weeks | ||
Secondary | Trail making test A and B | 24 weeks | ||
Secondary | Digit Span | 16 weeks | ||
Secondary | Digit Span | 24 weeks | ||
Secondary | Five Digits Test | 16 weeks | ||
Secondary | Five Digits Test | 24 weeks | ||
Secondary | Medication Appropriateness Index (MAI) | 16 weeks | ||
Secondary | Medication Appropriateness Index (MAI) | 24 weeks | ||
Secondary | Assessment of Underutilization (AOU) | 16 weeks | ||
Secondary | Assessment of Underutilization (AOU) | 24 weeks | ||
Secondary | Number of falls | Recorded with the aid of diaries kept by patients/caregivers | During the first 16 weeks after baseline | |
Secondary | Number of falls | Recorded with the aid of diaries kept by patients/caregivers | During the first 24 weeks after baseline | |
Secondary | Orthostatic blood pressure | 16 weeks | ||
Secondary | Orthostatic blood pressure | 24 weeks | ||
Secondary | Changes in body weight | 16 weeks | ||
Secondary | Changes in body weight | 24 weeks | ||
Secondary | Relative Stress Scale | 16 weeks | ||
Secondary | Relative Stress Scale | 24 weeks | ||
Secondary | Number of hospital admissions (with reasons) | During the first 16 weeks from baseline | ||
Secondary | Number of hospital admissions (with reasons) | During the first 24 weeks from baseline | ||
Secondary | Number of days in own home (in contrast to being in hospital or nursing home) | During the first 16 weeks from baseline | ||
Secondary | Number of days in own home (in contrast to being in hospital or nursing home) | During the first 24 weeks from baseline | ||
Secondary | Admission to permanent institutional care | 16 weeks | ||
Secondary | Admission to permanent institutional care | 24 weeks | ||
Secondary | Current use of home nursing service | 16 weeks | ||
Secondary | Current use of home nursing service | 24 weeks | ||
Secondary | Mortality | 16 weeks | ||
Secondary | Mortality | 24 weeks | ||
Secondary | Health-related quality of life as measured with 15D | 24 weeks |
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