VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532, United States
NCT Number: NCT05560451
The VetASSIST study is a randomized clinical trial testing whether receiving virtual health coaching from Veteran peers improves the physical and mental health-related quality of life of Veterans with multiple chronic health conditions and complex healthcare needs. VetASSIST will test the efficacy of an intervention that matches Veteran patients with multimorbidty with Veteran health coaches who will provide education, resources, guidance and support to help them manage their physical and mental health over the course of a year.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98108-1532, United States
The study objective is to evaluate the effectiveness of a virtual, Veteran peer-led self-management support program (VetASSIST) to improve health related quality of life (HRQoL) for Veterans with multimorbidity compared to usual care. The investigators will conduct a type 1 hybrid effectiveness-implementation randomized controlled trial of the intervention among VA Puget Sound patients with multimorbidity. Trained peer health coaches will virtually meet one-on-one with patients to assist in daily self-management by providing information; identifying patients' values and preferences; helping them set goals in alignment with their values and preferences and problem-solve barriers to those goals; modeling skills for effective management; providing social support; linking them to clinical care and community resources; and addressing self-management barriers. Veterans with multimorbidity will be randomized to receive the peer health coaching intervention or usual care. Outcomes will be assessed remotely at baseline and 12 months.
Specific aims are: 1) Test the effect of VetASSIST, compared to usual care, on the primary outcome of baseline to 12-month change in physical HRQoL, and secondary outcomes of mental HRQoL and health care utilization; 2a) Describe differences between VetASSIST and usual care on baseline to 12-month changes in intermediate outcomes reflecting the functions of peer support and intervention targets (self-efficacy, patient activation, health behaviors, social support, perceived access to care, patient-provider communication, and shared decision-making); 2b) Examine whether intermediate outcomes mediate intervention-associated differences in HRQoL; 3) Evaluate feasibility of translating VetASSIST into practice, including evaluation of per patient intervention costs and barriers and facilitators to implementation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eligible participants will be randomly assigned to receive a telehealth delivered peer health coach intervention to promote health outcomes and behavior change among Veterans with multimorbidty.
Other names: VetASSIST
Time frame: Baseline to 12-months
12 Item Short Form Health Survey (SF-12) Physical Component Summary: Summary scores for general health, physical functioning, role-physical, and bodily pain. Scaling scores will be assessed using published standardized scoring system procedures for the SF-12 found at: www.researchgate.net/publication/242636950_SF-12_How_to_Score_the_SF-12_Physical_and_Mental_Health_Summary_Scales
Time frame: Baseline to 12-months
12 Item Short Form Health Survey (SF-12) Mental Component Summary: Summary scores for vitality, mental health, social functioning, and role-emotional. Scaling scores will be assessed using published standardized scoring system procedures for the SF-12 found at: www.researchgate.net/publication/242636950_SF-12_How_to_Score_the_SF-12_Physical_and_Mental_Health_Summary_Scales
Time frame: Baseline to 12-months
Measured by VA clinical and administrative data and self-report responses (non-VA care), including primary care, specialty care, inpatient admissions, emergency department visits. A higher number of visits indicates greater utilization.
Time frame: Baseline to 12-months
Measured by the Self-Efficacy to Manage Chronic Disease Scale to assess perceived capability to perform actions required to manage chronic diseases. Confidence is measured on a 10-point scale ranging from (1) not at all confident to (10) totally confident. A higher score indicates higher self-efficacy/confidence.
Time frame: Baseline to 12-months
Measured by the Consumer Health Activation Index (CHAI) to assess ability to take preventive actions, manage symptoms, find and use medical care, and work with health care providers. Responses are measured as low activation vs. not low activation on a 4-point scale ranging from almost always true (1) to almost never true (4). A higher score indicates lower activation.
Time frame: Baseline to 12-months
Medical Outcomes Study (MOS) 8-Item Social Support Survey Instrument will measure emotional, instrumental, informational, and appraisal of social support. Social Support is scored using a 5-point response scale ranging from none of the time (1) to all of the time (5). A higher score for an individual scale or overall support index indicates greater support.
Time frame: Baseline to 12-months
Three-Item UCLA Loneliness Scale will measure subjective feelings of being lonely or isolated. Responses are measured using a 3-point response scale ranging from hardly ever (1) to often (3). A higher score indicates greater loneliness.
Time frame: Baseline to 12-months
Consumer Assessment of Healthcare Providers and Systems (CAHPS) - access to care- will measure getting timely appointments, care, and information. Responses are measured using a 4-point response scale ranging from never (1) to always (4). A higher score indicates increased access to care.
Time frame: Baseline to 12-months
Consumer Assessment of Healthcare Providers and Systems (CAHPS) - patient-provider communication- will measure communication with physician and health care team. Responses are measured using a 4-point response scale ranging from never (1) to always (4). A higher score indicates greater communication.
Time frame: Baseline to 12-months
CollaboRATE will measure explanation of health issues; elicitation and integration of patient preferences. Responses are measured using a 10-point response scale ranging from no effort was made (0) to every effort was made (9). A higher score indicates greater shared decision making.
Time frame: Baseline to 12-months
Starting the Conversation brief dietary assessment and intervention scale will measure diet quality. Responses are measured using a 3-point response scale. Items have a score range of 0, 1, 2. The total ranges from scores of 0 to 16. A higher score indicates a less healthful diet.
Time frame: Baseline to 12-months
Voils Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) Reasons for Nonadherence measure will identify possible reasons for nonadherence to prescribed treatment. Medication adherence is scored using a 5-point response scale ranging from none of the time (1) to all of the time (5). Higher scores indicate greater nonadherence.
Time frame: Baseline to 12-months
Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire will measure tobacco use. Questions will assess current tobacco use and frequency of use. Current tobacco use includes individuals who report having smoked at least 100 cigarettes in their entire life and who report smoking cigarettes now (every day or some days).
Time frame: Baseline to 12-months
AUDIT Alcohol Consumption questionnaire (AUDIT-C) will measure alcohol use. A total of 5+ indicates increased or higher risk drinking. An overall total score of 5 or above is AUDIT-C positive.
Time frame: Baseline to 12-months
PROMIS Sleep Related Impairment and Sleep Disturbance survey will measure sleep disturbance related impairment. Responses are measured on a 5-point scale ranging from not at all (1) to very much (5). A higher score indicates greater sleep disturbance.
Time frame: Baseline to 12-months
International Physical Activity Questionnaire (IPAQ) Short form assessment will measure physical activity. We will examine total physical activity in minutes per week, totaling all time from walking, moderate, and vigorous activity in the past 7 days. We will also examine physical activity dichotomously, identifying those meeting recommendations of at least 150 minutes total physical activity per week. We will use standard data cleaning procedures outlined by IPAQ developers, available at www.ipaq.ki.se.
VA Office of Research and Development
Fed
Acronym: VetASSIST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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