- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02915562
Influence of Depressive Mood on Rehab Outcome
September 23, 2016 updated by: Johannes Kepler University of Linz
Influence of Depressive Mood on Short Term Rehab Outcome at an Acute Geriatrics Unit
The purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
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
-
-
-
Linz, Austria, 4020
- Recruiting
- Kepler University Hospital
-
Contact:
- Christian Mittermaier, M.D.
- Email: christian.mittermaier@akh.linz.at
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 2-week in-house-rehab at an acute geriatric unit
- ability to take part in assessments
- understanding German language
- Informed Consent
Exclusion Criteria:
- anti-depressive medication shorter than 4 weeks before enrollment
- In-house rehab < 14 days
- advanced stage of dementia
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Depressive Group
GDS 15 (Geriatric Depression Score) ≥5 at baseline
|
|
|
Active Comparator: Non-depressive Group
GDS 15 (Geriatric Depression Score) <5 Points at baseline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Performance Test
Time Frame: Change from baseline at day 14 +/-1
|
Change from baseline at day 14 +/-1
|
|
|
de Morton Mobility Index
Time Frame: Change from baseline at day 14 +/-1
|
The de Morton Mobility index is a method for measuring changes in mobility and enhancing the continuity of patient care across clinical settings
|
Change from baseline at day 14 +/-1
|
|
Performance Orientated Mobility Assessment (POMA)
Time Frame: Change from baseline at day 14 +/-1
|
Task-oriented outcome measure that assesses gait and balance ability
|
Change from baseline at day 14 +/-1
|
|
Barthel Index
Time Frame: Change from baseline at day 14 +/-1
|
The Barthel index is an ordinal scale used to measure performance in activities of daily living
|
Change from baseline at day 14 +/-1
|
|
Function Index Physiotherapy
Time Frame: Change from baseline at day 14 +/-1
|
Change from baseline at day 14 +/-1
|
|
|
Function Index Occupational Therapy
Time Frame: Change from baseline at day 14 +/-1
|
Change from baseline at day 14 +/-1
|
|
|
Grip strength measurement
Time Frame: Change from baseline at day 14 +/-1
|
measured with JAMAR dynamometer
|
Change from baseline at day 14 +/-1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Charlson Comorbidity Index
Time Frame: Day 1+/-1
|
Measure of comorbidity and multimorbidity
|
Day 1+/-1
|
|
Timed Test of Money Counting
Time Frame: Day 1+/-1
|
Day 1+/-1
|
|
|
Geriatric Depression Scale (GDS-15)
Time Frame: Day 1+/-1 and day 14+/-1
|
Day 1+/-1 and day 14+/-1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
April 1, 2016
Primary Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Estimate)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PMR-AGR-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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