Chronic Medical ConditionsFACE-PCNCT03094871
FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care
A study testing FACE-PC in people with Chronic Medical Conditions and Depression, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Medical Conditions, Depression
- What is being tested?
- FACE-PC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Age 18 or older
- Identified as family by the patient
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
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.
- Conditions
- Chronic Medical Conditions, Depression
- Being tested
- FACE-PC
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACE-PCBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mood assessed with Patient Health Questionnaire
Patient Health Questionnaire
Measured: at baseline, 2-months post-intervention, and 5-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Apr 2015
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Medical ConditionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mijung Park, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094871
- Sponsor's protocol ID
- 17-23224
- Acronym
- FACE-PC
- Status last verified
- Nov 2021
- First submitted
- 20 Mar 2017
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FACE-PC: Family-Centered Care for Older Adults With Depression and Chronic Medical Conditions in Primary Care
- ClinicalTrials.gov ID
- NCT03094871
- Acronym / sponsor ID
- FACE-PC / 17-23224
- Conditions
- Chronic Medical Conditions, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FACE-PCFACE-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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Age 18 or older
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACE-PC | Behavioural | Intervention group |
Primary outcome
Changes in Mood assessed with Patient Health Questionnaire
Time frame: at baseline, 2-months post-intervention, and 5-months follow-up
Patient Health Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mijung Park, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FACE-PC in people with Chronic Medical Conditions and Depression, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mood assessed with Patient Health Questionnaire (time frame: at baseline, 2-months post-intervention, and 5-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.