NCT01925105

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

August 13, 2013

Last Update Submit

September 14, 2015

Conditions

Keywords

Polypharmacy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Readmission to hospital

    1 year from baseline

Other Outcomes (1)

  • The quality of drug treatment

    1 year from baseline

Study Arms (2)

Optimization of treatment

EXPERIMENTAL

Optimization of treatment of diseases and symptoms

Other: Experimental: Optimization of treatment

Control

PLACEBO COMPARATOR

Treatment as usual

Interventions

Optimization of treatment of diseases and symptoms

Optimization of treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychosis
  • Not understand the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro County Council

Örebro, Örebro County, 70116, Sweden

Location

Study Officials

  • Peter Engfeldt, Professor

    Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 19, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations