Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03094871
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mijung Park, University of California, San Francisco

Brief Summary:
Comorbid depression and multiple medical conditions in older adults are a serious public health problem. As an important facilitator of health-related activities, families are already involved in various aspects of self-management of chronic disease in older adults. Despite the benefits they provide, informal caregiving activities currently are organized outside the medical system, which potentially creates redundant or misaligned efforts.The purpose of the mentored research is to examine the feasibility and acceptability of the FACE-PC, a theory-driven, multi- component, technology-assisted interdisciplinary team-based care model that systematically involves family in chronic disease management. It aims to optimize the patient and family's collective ability to self-manage chronic disease.

Condition or disease Intervention/treatment Phase
Chronic Medical Conditions Depression Behavioral: FACE-PC Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care
Actual Study Start Date : April 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
FACE-PC comprises 3 weekly and 2 bi-weekly sessions (total 5 sessions), delivered by a bachelors' prepared nurse care manager (CM) over 8 weeks. Over the five sessions, the nurse care manager will (1) review the patient medical history and set health goals for depression and chronic condition with the dyad, (2) review all medication, the level of adherence, challenges and facilitating factors of adherence, (3) deliver brief behavioral activation therapy.
Behavioral: FACE-PC
No Intervention: Enhanced usual care group
Participants in this group will receive a typical primary care enhanced with reporting of their depression status and their goal for medical condition to their PCP for 8 weeks. Upon enrolment, a research nurse will review the patient medical history and identify goals for depression and a chronic condition with the dyad.



Primary Outcome Measures :
  1. Changes in Mood assessed with Patient Health Questionnaire [ Time Frame: at baseline, 2-months post-intervention, and 5-months follow-up ]
    Patient Health Questionnaire



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Patient:

  • 60 years of age or older
  • Receives primary care
  • PHQ-9 score ≥ 5
  • Must have at least one medical condition actively managed at the study site.

Inclusion Criteria for Family:

  • Age 18 or older
  • Identified as family by the patient
  • Has a minimum of twice weekly total of 4 hour face-to face contact with the patient
  • Is willing and available to participate in the study;
  • Has access to internet.

Exclusion Criteria for Patient:

  • Inability to understand screening and assessment questions
  • Montreal Cognitive Assessment Scores <18
  • Known diagnosis of a severe chronic mental illness such as schizophrenia
  • Meeting the criteria for bipolar disorder or schizophrenia in PRIME-MD
  • Deemed to be a danger to self or others that may require treatment outside a primary care setting.

Exclusion Criteria for Family:

  • Institutionalized at the time of study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094871


Contacts
Layout table for location contacts
Contact: Mijung Park, PhD 415-502-5628 mijung.park@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Mijung Park, PhD         
Sponsors and Collaborators
University of California, San Francisco

Layout table for additonal information
Responsible Party: Mijung Park, PhD, MPH, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03094871     History of Changes
Other Study ID Numbers: PRO14040546
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes