Effectiveness of a Depression Care Management Initiative in Home Healthcare

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01979302
First received: September 26, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

Depression in older home healthcare patients occurs very often, is typically not treated appropriately, and leads to poor health outcomes. This study tests an intervention, called "Depression Care for Patients at Home" or the Depression CAREPATH, designed to help home healthcare nurses work with the patients, their family, and their doctors in managing depression treat depression according to clinical guidelines and to manage its treatment over time. Patient outcomes, measured at 3, 6, and 12 months, include guideline-consistent changes in depression treatment and reduction in depressive symptoms.


Condition Intervention
Depression
Other: Depression CAREPATH
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Depression Care Management Initiative in Home Healthcare

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Depression Severity [ Time Frame: 2 week ] [ Designated as safety issue: No ]
    Assessment of depression severity using the Hamilton Depression Rating Scale


Secondary Outcome Measures:
  • Guideline Consistent change in depression treatment [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    Patient home healthcare records reviewed for evidence that patients received a change in depression treatment (e.g., antidepressant initiation, dose change, augmentation, switch)


Estimated Enrollment: 310
Study Start Date: January 2009
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depression CAREPATH
Patients receiving care from Nurses trained in depression care management
Other: Depression CAREPATH
Nurses receive training and agency support in depression assessment and depression care management
Usual Care
Patients under the care of nurses who were trained in depression assessment and usual care
Other: Usual Care
Nurses receive training in depression assessment and review of usual care procedures.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New home healthcare patient
  • Age 65 years or older
  • Depressed Mood or Anhedonia recorded by visiting nurse
  • English or Spanish speaking

Exclusion Criteria:

  • High suicide risk, i.e. intent or plan to attempt suicide in near future as defined by the suicide risk assessment.
  • Significant Cognitive Impairment: Mini-mental Status Exam below 20
  • Severe hearing impairment or aphasic
  • Life expectancy less than 6 months (CMS 485)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01979302

Locations
United States, New York
Weill Cornell Medical College, Westchester Division
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Martha L Bruce, PhD, MPH Weill Medical College of Cornell University
  More Information

Additional Information:
Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01979302     History of Changes
Other Study ID Numbers: R01 MH082425
Study First Received: September 26, 2013
Last Updated: July 9, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Geriatric Depression
Depression Care Management
home healthcare
nurse training intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014