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

NCT03094871 | Completed

• 1 other identifier: 17-23224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Medical Conditions; Depression

Outcome Measures

Primary Outcomes (1)

• Changes in Mood assessed with Patient Health Questionnaire

  Patient Health Questionnaire

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Enhanced usual care group

NO INTERVENTION

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

FACE-PC BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Institutionalized at the time of study.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mijung Park, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 29, 2017
• Study Start: April 1, 2015
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)