Comprehensive Geriatric Assessment - Can it Improve Quali... | NCT01925105

Studies
Comprehensive Geriatric Assessment - Can it Improve Quality of Life

NCT01925105

Sponsor

Örebro County Council

Status

Unknown status

Last Update Posted

Sep 15, 2015Estimated

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Quality of Life

Interventions

Experimental: Optimization of treatment

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Apr 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Aug 13, 2013

First Submission Date that Met QC Criteria

Aug 15, 2013

First Posted Date

Aug 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2015

Last Update Posted Date

Sep 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optimization of treatment	Experimental	Optimization of treatment of diseases and symptoms	Other: Experimental: Optimization of treatment
Control	Placebo Comparator	Treatment as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental: Optimization of treatment	Other	Optimization of treatment of diseases and symptoms	Optimization of treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retained or increased quality of life of at least 20% measured by EQ-5D (EuroQOL) after 1 year from baseline.		1 year from baseline

Secondary Outcomes

Measure	Description	Time Frame
Readmission to hospital		1 year from baseline

Other Outcomes

Measure	Description	Time Frame
The quality of drug treatment		1 year from baseline

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Engfeldt, Professor	Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Örebro County Council		Örebro	Örebro County	70116	Sweden