INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wellness Program.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
In this study, the investigators will evaluate the feasibility of the Wellness Program, including patient recruitment, screening and outcome measures, and feasibility of adapting the intervention with older Black surgical patients who endorse clinically significant symptoms of depression and/or anxiety.
Interventions
- Behavioral Wellness Program
The BCBT intervention consists of 8 to 10 structured sessions delivered remotely via phone or Zoom, beginning in the preoperative period and continuing for approximately three months after surgery. The interventionist will offer a protocolized review of current medications with feedback as appropriate, under guidance by the study psychiatrist. As additional optional components of the Wellness Program, the study team will also offer faith-based counseling as well as the option to involve family
Primary outcome measures
- Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate [Time frame: Through completion of enrollment for all participants (estimated to be 9 months, time for participant 1 day)]
- Reach of the intervention as measured by number of patients who completed the intervention out of patients who agreed to participate in the study [Time frame: Through completion of follow-up for all participants (estimated to be 12 months, time for participant 3 months)]
Secondary outcome measures (1)
- Percentage of instrument or data fields completed for Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) [Time frame: Baseline, 1 month after surgery, and 3 months after surgery]
Eligibility criteria
Inclusion Criteria Patients:
- Age ≥60 years
- Scheduled surgical procedure at BJH or BJWCH (oncologic, cardiac; orthopedic)
- Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10
- Black or African American.
Exclusion Criteria Patients:
- Inability to provide informed consent;
- Severe cognitive impairment screened by the SBT (Short Blessed Test) ≥10
- Acutely suicidal
- Considered ineligible per the discretion of the surgeon or study PI
- Considered ineligible per the discretion of the surgeon or study PI
Caregiver participants:
If patients identify a caregiver that the patient would like to include in their Wellness Program, the caregiver will be invited to consent. Patients will provide contact information for their caregiver.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07283783 · 202511072