Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT05560451
Eligibility Criteria:
Inclusion Criteria:
* Veteran patient receiving primary care from VA Puget Sound
* Complex multimorbidity (\>=3 chronic conditions in \>=3 body systems based on AHRQ Chronic Condition Index)
* Meets \>=2 criterion from NICE multimorbidity guidelines: 1) have a chronic physical and mental health condition (via ICD-10 codes in CDW and the CCI); 2) frailty (determined by the JEN Frailty Index available in VA data, confirmed via self-reported PRISMA-7 during the eligibility screening; 3) frequent emergency care (\>=1 VA emergency department visit in past year via CDW); 4) polypharmacy (\>=10 prescribed medications via CDW), or 5) significant treatment burden (score \>22 on the self-reported Multimorbidity Treatment Burden Questionnaire at study screening).
* Inclusion criteria assessed via the phone screen includes frailty; treatment burden; and willingness to use a either a phone or an Internet-connected device with a web camera and an email address and/or ability to receive text messages to ensure receipt of VVC visit links.
* Agree to participate in the health coaching sessions and surveys if assigned to intervention group
Exclusion Criteria:
* Not fluent in English
* Severe hearing loss
* No phone access and/or missing phone number
* Missing address
* Diagnosis of dementia or severe cognitive impairment within last year
* Diagnosis of end stage renal disease or on dialysis within last year
* Receipt of palliative or hospice care in the past year
* Receipt of nursing home care in past year (Stop codes: 650, 651,119,121)
* Currently living in a nursing home, skilled nursing facility, rehabilitation facility, or long-term care facility
* Behavior flags in EHR
* Active treatment for non-melanoma skin cancer diagnosis
* Diagnosis of substance use dependence/abuse disorder in last year (excluding tobacco)
* Diagnosis of psychotic disorder in last year
* Pregnant or planning to become pregnant in next 6 months
* Score of \>8 (severe risk) on self-reported AUDIT-C questions on eligibility screen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05560451
Study Brief:
Protocol Section:
NCT05560451