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

Primary Purpose

Chronic Medical Conditions, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FACE-PC
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Medical Conditions

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Enhanced usual care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Mood assessed with Patient Health Questionnaire
Patient Health Questionnaire

Secondary Outcome Measures

Full Information

First Posted
March 20, 2017
Last Updated
November 5, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03094871
Brief Title
FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care
Acronym
FACE-PC
Official Title
FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Medical Conditions, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced usual care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FACE-PC
Primary Outcome Measure Information:
Title
Changes in Mood assessed with Patient Health Questionnaire
Description
Patient Health Questionnaire
Time Frame
at baseline, 2-months post-intervention, and 5-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mijung Park, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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