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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT03094871
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
69
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: FACE-PC
N/A

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.

Study Design

Study Type:
Interventional
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 :
Apr 1, 2015
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

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

    Patient Health Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of California San FranciscoSan FranciscoCaliforniaUnited States94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Mijung Park, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03094871
Other Study ID Numbers:
  • 17-23224
First Posted:
Mar 29, 2017
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2021