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

Status

Unknown

Conditions

Intervention / Treatment

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

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.

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

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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