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

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. Read our disclaimer for details. Identifier: NCT03094871
Recruitment Status : Active, not recruiting
First Posted : March 29, 2017
Last Update Posted : November 17, 2020
Information provided by (Responsible Party):
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

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Study Type : Interventional  (Clinical Trial)
Actual 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 1, 2015
Actual Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

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

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

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 identifier (NCT number): NCT03094871

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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Mijung Park, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT03094871    
Other Study ID Numbers: 17-23224
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes