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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03094871
Other study ID # 17-23224
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2015
Est. completion date December 30, 2020

Study information

Verified date November 2021
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
FACE-PC


Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Mood assessed with Patient Health Questionnaire Patient Health Questionnaire at baseline, 2-months post-intervention, and 5-months follow-up
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