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CompletedNCT03094871FACE-PCUpdated Nov 15, 2021

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

An interventional study of FACE-PC in Chronic Medical Conditions and Depression, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-15.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2015, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Medical Conditions
  • Depression
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In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 732 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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.

Interventions

  • BehavioralFACE-PC
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What researchers measure

Primary outcomes

  1. Changes in Mood assessed with Patient Health Questionnaire

    Patient Health Questionnaire

    Time frame: at baseline, 2-months post-intervention, and 5-months follow-up

07

Study locations

1 site
  • University of California San Francisco
    San Francisco, California 94143, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03094871
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Mar 29, 2017
Start date
Apr 1, 2015
Primary completion
Dec 30, 2020
Completion
Dec 30, 2020
Last update
Nov 15, 2021

Study contacts

Mijung Park, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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