Diabetes
Conditions
Keywords
peer support, mental health, diabetes self-management, community-based participatory research
Brief summary
Patients with diabetes are often challenged by the routine of managing their diabetes, and may experience both stress and medical problems. Diabetes-related medical problems and stress often happen together and affect peoples' ability to live a full, happy and healthy life. Because of this, programs that help with medical problems and stress by teaching ways to better manage diabetes and stress may improve the lives of those with diabetes. Many excellent programs are available in the VA and in the community that help persons with diabetes better manage their medical problems and stress, but often times Veterans have trouble finding these programs. The purpose of the study is to see if a telephone-based coaching program improves the physical and emotional health of Veterans with diabetes more than use of a directory of community and VA resources and no coaching. The Veterans who receive the directory of community and VA resources will be given this at the beginning of the study and will access resources as they see fit. Those in the coaching program will be coached by a Veteran with knowledge of diabetes, mental health and community resources who will help them connect to care in the VA and/or community depending on their preference. Examples of resources available in the VA and community include mental health care and programs to help with diet, exercise and learning about how to better manage diabetes. Veterans who are interested in participating and pass screening will be enrolled in the study for about 6 months. Each enrolled Veteran will have a 50% chance of being enrolled in the coaching group and a 50% chance of being enrolled in the directory group (like the flip of a coin). Both groups will be asked to complete several questionnaires about their health and well-being by telephone. This will occur at the beginning of the study and three and six months later. The questionnaires will take about an hour to complete each time.
Detailed description
Diabetes-related distress, the negative emotional impact of living with diabetes (DM), is a powerful predictor of psychosocial functioning, treatment adherence, and glycemic control. Practice guidelines and consensus statements call for innovative approaches to address DM-related distress. Despite availability of self-management and psychosocial interventions to reduce DM related distress, these interventions are underutilized due to constraints in time, finances, motivation, and resource-awareness. Interventions that leverage traditional medical care and community-based health promotion programs (e.g., DM self-management education (DSME) programs) may enhance the ability of Veterans with DM to engage with a broad and accessible range of resources. Ensuring that Veterans with DM receive adequate self-care support requires interventions that (1) attend to both medical care and diabetes-related distress and (2) improve Veterans' access and engagement with DSME and traditional medical/mental care. Integrating VA and community health services and DSME resources is innovative and affords great opportunities to enhance Veteran outcomes and build VA community partnerships. Engagement of Veterans and community organizations in developing and delivering care responds to the 2016 HSR&D high-priority domain of Health Care Systems Change and aligns with the 2017 VA Under Secretary's priorities of Greater Choice (offering community and VA resources), Efficiency (community and VA coordination), and Timeliness (telephone delivery). This community-VA partnership and three-month Veteran peer coaching intervention (iNSPiRED) aims to enhance psychological well-being and diabetes self-management behavior in Veterans with DM by facilitating access to and use of healthcare and health promotion resources. The intervention focuses on reducing cognitive and practical barriers to use of services by engaging Veteran peers as coaches and navigators, and by encouraging engagement in health promotion and healthcare services in the VA and the greater community. A secondary goal, integral to the main goal, is to strengthen and integrate VHA partnerships with community-based organizations and Veteran Support Organizations (VSO's). This is a single-blind, parallel group randomized trial of a 3-month peer navigation intervention for Veterans with DM and elevated levels of DM-related distress. The investigators will recruit Veterans with DM-related distress through existing help-seeking channels within and outside of the VA in partnership with community agencies, VSO's, and the Houston VAMC. Eligible Veterans will be assigned at random to the iNSPiRED intervention (peer navigation and coaching) versus usual care (written resource materials and encouragement to continue follow-up with healthcare providers). Consistent with the focus on the overall emotional impact of DM, the PRIMARY OUTCOME is DM-related distress (DM Distress Scale). In previous studies the DDS has shown strong relationships with psychological symptoms, self-management behaviors, and objective measures of glycemic control. SECONDARY OUTCOMES include anxiety symptoms (Generalized Anxiety Disorder Scale), depression symptoms (Patient Health Questionnaire-8), DM self-management behaviors (DM Self-Management Scale), and self-reported use and new use of VA or community resources. In addition to participant-level outcomes, the investigators will also assess STAKEHOLDER OUTCOMES through a mixed methods process evaluation. The objective will be to measure the impact of stakeholder engagement activities on development and sustainability of VA-community partnerships, trust and communication, and capacity building. Assessment of primary and secondary endpoints will occur at baseline, post-intervention, and at 6 months. If this project meets intended goals, the investigators will partner with VHA Office of Community Engagement and VHA Specialty Care to implement the intervention for DM and other chronic diseases.
Interventions
BEHAVIORALiNSPiRED
The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
OTHERUsual Care
Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This is a single-blind, parallel group, randomized trial of a 3-month peer-navigation intervention for Veterans with DM and elevated levels of diabetes-related distress. Participants will be assigned at random (see below) to the intervention (peer navigation with follow-up) or usual care (print materials and encouragement to continue follow-up with health care providers). Assessment of primary, secondary and intermediate end points will occur pre-intervention at baseline and post-intervention at 3 and 6 months.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Veteran * Diagnosis of type 2 DM, per self-report * Moderate diabetes-related distress (Diabetes Distress Scale \[DDS2\] mean score of 3 or greater)
Exclusion criteria
* Lack of reliable access to a telephone * Cognitive, sensory, or other impairment that prevents use of a telephone * Current participation in another diabetes-related counseling or self-management program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Distress Screening Scale (DDS17) | Baseline, Month 3, Month 6 | The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden (Feeling angry, scared and/or depressed when I think about living with diabetes), Physician-related Distress (Feeling that my doctor doesn't take my concerns seriously enough), Regimen-related Distress (Not feeling confident in my day-to-day ability to manage diabetes), and Interpersonal Distress (Feeling that friends or family don't give me the emotional support that I would like). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline, Month 3, Month 6 | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, fruits and vegetable intake, fat intake, physical activity, blood-glucose testing, and foot care. and smoking. Minimum score 0. Maximum score 7 (for each area). Higher scores indicate better self care. Smoking in the last week is also assessed as a binary variable (see separate entry). |
| Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Baseline, Month 3, Month 6 | The SDSCA measure is a brief self-report questionnaire of diabetes self-management. Any smoking in the last week is assessed as a binary variable. Minimum score 0 (did not smoke). Maximum score 1 (smoked). See separate entry for SDSCA items that measure the number of days per week an activity is performed. Reported counts reflect number of participants who indicated smoking in the last week. |
| Change in Patient Health Questionnaire-8 (PHQ-8) | Baseline, Month 3, Month 6 | The PHQ-8 is an eight-item questionnaire that assesses the frequency of depression and mood-related symptoms (e.g., Feeling down, depressed, or hopeless, Trouble falling or staying asleep, or sleeping too much) over the past 2 weeks. Minimum score 0. Maximum score 24. Higher scores indicate worse depression. |
| Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Baseline, Month 3, Month 6 | The GAD-7 is a 7-item questionnaire developed as a companion to the PHQ-9 to screen for generalized anxiety disorder and other common anxiety disorders. Items assess the frequency of anxiety symptoms (e.g., Worrying too much about different things, Feeling afraid as if something awful might happen) over the past 2 weeks. Minimum score 0. Maximum score 21. Higher scores indicate worse anxiety. |
| Change in Use of Community Resources (no to Yes) | Baseline, Month 6 | The investigators will record the Veteran's self-report of any use of community-based resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous. Yes = care in the community. No= no care in the community |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Use of VHA Resources (no to Yes) | Baseline, Month 6 | The investigators will record the Veteran's self-report of use of VHA resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous Yes = care in VHA. No= no care in VHA. |
| Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey | Baseline and every 12 months assessed up to month 48. | The investigators will measure engagement from the community partner perspective using the PCORI WE-ENACT Patient and Stakeholder Survey, completed annually. This measure includes items to describe engagement from the stakeholder's point of view. One or two key representatives from each community partner agency will participate. The Outcome Measure Data Table includes the number of participants who completed the survey. |
| Change in Patient Activation Measure (PAM) | Baseline, Month 3, Month 6 | The Patient Activation Measure (PAM) is designed to measure the extent to which patients endorse subjective ability to self-manage their chronic health conditions. Items assess several aspects of self-management, including knowledge (e.g., I know what each of my prescribed medications do), skill (e.g., I have been able to maintain the lifestyle changes for my health that I have made), and confidence (e.g., I am confident I can tell my health care provider concerns I have even when he or she does not ask). Raw scores: Minimum 13. Maximum 52. Scaled scores (Activation scores): Minimum 0.0. Maximum 100.0. Higher scores indicate more patient activation. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Baseline, Month 3, Month 6 | PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a measures self-efficacy related to managing emotions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 24.82 Maximum score 63.45. Higher scores indicate higher self-efficacy. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Baseline, Month 3, Month 6 | PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a measures self-efficacy related to managing daily activities. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 26.02 Maximum score 59.26. Higher scores indicate higher self-efficacy. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Baseline, Month 3, Month 6 | PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a measures self-efficacy related to managing social interactions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 23.08 Maximum score 58.19. Higher scores indicate higher self-efficacy. |
| Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey | Baseline and every 12 months assessed up to month 48 | The investigators will measure stakeholder engagement from the researcher's perspective using a modified version of the PCORI WE-ENACT Researcher Survey, completed annually. One group of researchers (the primary investigator and three team members) involved in stakeholder engagement completed the survey together at each time point. The Outcome Measure Data Table includes the number of participants who completed the survey (1 group of researchers). |
Countries
United States
Participant flow
Recruitment details
Of the 1,614 Veterans considered for study entry (1,499 referred from VA sources, 110 referred from community sources, 5 referred from both VA and community sources), 1,109 were contacted, 503 were screened, and 219 were eligible/provided informed consent for study participation.
Pre-assignment details
One participant who provided informed consent withdrew prior to completing baseline/randomization.
Participants by arm
| Arm | Count |
|---|---|
| iNSPiRED Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided. | 110 |
| Usual Care Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations | 108 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Phase | Death | 2 | 0 |
| Follow-up Phase | Lost to Follow-up | 2 | 1 |
| Follow-up Phase | Too ill | 3 | 0 |
| Intervention Phase | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | iNSPiRED | Usual Care | Total |
|---|---|---|---|
| 17-item Diabetes Distress Scale (DDS17)--Total Score | 3.04 units on a scale STANDARD_DEVIATION 1.11 | 3.06 units on a scale STANDARD_DEVIATION 1.07 | 3.05 units on a scale STANDARD_DEVIATION 1.08 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 53 Participants | 49 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 59 Participants | 116 Participants |
| Age, Continuous | 63.35 years STANDARD_DEVIATION 10.31 | 62.37 years STANDARD_DEVIATION 11.13 | 62.86 years STANDARD_DEVIATION 10.71 |
| Annual Income <$20k | 41 Participants | 40 Participants | 81 Participants |
| Annual Income $20k-$39,999k | 29 Participants | 24 Participants | 53 Participants |
| Annual Income $40k-$59,999k | 23 Participants | 22 Participants | 45 Participants |
| Annual Income $60k + | 17 Participants | 22 Participants | 39 Participants |
| Education Bachelors Degree | 21 Participants | 17 Participants | 38 Participants |
| Education Graduate or Professional Degree | 8 Participants | 11 Participants | 19 Participants |
| Education High School/GED/No Diploma | 35 Participants | 30 Participants | 65 Participants |
| Education Some College or Technical School | 46 Participants | 50 Participants | 96 Participants |
| Ever hospitalized for diabetes No | 83 Participants | 82 Participants | 165 Participants |
| Ever hospitalized for diabetes Yes | 27 Participants | 26 Participants | 53 Participants |
| Race/Ethnicity, Customized Race Black | 57 Participants | 59 Participants | 116 Participants |
| Race/Ethnicity, Customized Race Hispanic | 22 Participants | 13 Participants | 35 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Race White | 25 Participants | 31 Participants | 56 Participants |
| Region of Enrollment United States | 110 Participants | 108 Participants | 218 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 98 Participants | 95 Participants | 193 Participants |
| Uses any diabetes medication No | 3 Participants | 2 Participants | 5 Participants |
| Uses any diabetes medication Yes | 107 Participants | 106 Participants | 213 Participants |
| Uses insulin No | 54 Participants | 59 Participants | 113 Participants |
| Uses insulin Yes | 56 Participants | 49 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 110 | 0 / 108 |
| other Total, other adverse events | 1 / 110 | 0 / 108 |
| serious Total, serious adverse events | 12 / 110 | 11 / 108 |
Outcome results
Primary
Change in Diabetes Distress Screening Scale (DDS17)
The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden (Feeling angry, scared and/or depressed when I think about living with diabetes), Physician-related Distress (Feeling that my doctor doesn't take my concerns seriously enough), Regimen-related Distress (Not feeling confident in my day-to-day ability to manage diabetes), and Interpersonal Distress (Feeling that friends or family don't give me the emotional support that I would like). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress.
Time frame: Baseline, Month 3, Month 6
Population: Full sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Total Score | 3.0 score on a scale | Standard Deviation 1.1 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Regimen-Related Distress Subscale | 2.8 score on a scale | Standard Deviation 1.2 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Interpersonal Distress Subscale | 2.4 score on a scale | Standard Deviation 1.4 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Interpersonal Distress Subscale | 2.3 score on a scale | Standard Deviation 1.4 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Physician-Related Distress Subscale | 2.7 score on a scale | Standard Deviation 1.3 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Total Score | 2.6 score on a scale | Standard Deviation 1 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Total Score | 2.6 score on a scale | Standard Deviation 1.1 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Emotional Burden | 2.7 score on a scale | Standard Deviation 1.2 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Emotional Burden Subscale | 3.3 score on a scale | Standard Deviation 1.3 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Physician-Related | 2.4 score on a scale | Standard Deviation 1.1 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Emotional Burden Subscale | 2.7 score on a scale | Standard Deviation 1.2 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Regimen-Related | 2.8 score on a scale | Standard Deviation 1.1 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Regimen-Related Distress Subscale | 3.5 score on a scale | Standard Deviation 1.3 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Interpersonal | 2.4 score on a scale | Standard Deviation 1.4 |
| iNSPiRED | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Physician-Related Distress Subscale | 2.4 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Interpersonal | 2.2 score on a scale | Standard Deviation 1.3 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Emotional Burden Subscale | 3.3 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Physician-Related Distress Subscale | 2.6 score on a scale | Standard Deviation 1.3 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Regimen-Related Distress Subscale | 3.5 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Interpersonal Distress Subscale | 2.6 score on a scale | Standard Deviation 1.5 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Total Score | 2.4 score on a scale | Standard Deviation 1.4 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Emotional Burden Subscale | 2.8 score on a scale | Standard Deviation 1.1 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Physician-Related Distress Subscale | 2.4 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Regimen-Related Distress Subscale | 3.0 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 3--Interpersonal Distress Subscale | 2.2 score on a scale | Standard Deviation 1.3 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Total Score | 2.6 score on a scale | Standard Deviation 1 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Emotional Burden | 2.7 score on a scale | Standard Deviation 1.1 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Physician-Related | 2.4 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Month 6--Regimen-Related | 2.9 score on a scale | Standard Deviation 1.2 |
| Usual Care | Change in Diabetes Distress Screening Scale (DDS17) | Baseline--Total Score | 3.1 score on a scale | Standard Deviation 1.1 |
Comparison: Total Score - Treatment Effect - Month 3p-value: 0.42Mixed Models Analysis
Comparison: Emotional Burden Subscale - Treatment Effect - Month 3p-value: 0.32Mixed Models Analysis
Comparison: Physician-Related Distress Subscale - Treatment Effect - Month 3p-value: 0.36Mixed Models Analysis
Comparison: Regimen-Related Distress Subscale - Treatment Effect - Month 3p-value: 0.23Mixed Models Analysis
Comparison: Interpersonal Distress Subscale - Treatment Effect - Month 3p-value: 0.26Mixed Models Analysis
Comparison: Total Score - Treatment Effect - Month 6p-value: 0.95Mixed Models Analysis
Comparison: Emotional Burden Subscale - Treatment Effect - Month 6p-value: 0.92Mixed Models Analysis
Comparison: Physician-Related Distress Subscale - Treatment Effect - Month 6p-value: 0.59Mixed Models Analysis
Comparison: Regimen-Related Distress Subscale - Treatment Effect - Month 6p-value: 0.54Interaction Term
Comparison: Interpersonal Distress Subscale - Treatment Effect - Month 6p-value: 0.05Mixed Models Analysis
Secondary
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
The GAD-7 is a 7-item questionnaire developed as a companion to the PHQ-9 to screen for generalized anxiety disorder and other common anxiety disorders. Items assess the frequency of anxiety symptoms (e.g., Worrying too much about different things, Feeling afraid as if something awful might happen) over the past 2 weeks. Minimum score 0. Maximum score 21. Higher scores indicate worse anxiety.
Time frame: Baseline, Month 3, Month 6
Population: Full sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Baseline | 10.9 units on a scale | Standard Deviation 7 |
| iNSPiRED | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Month 3 | 9.3 units on a scale | Standard Deviation 6.8 |
| iNSPiRED | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Month 6 | 9.6 units on a scale | Standard Deviation 6.9 |
| Usual Care | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Baseline | 11.4 units on a scale | Standard Deviation 6.4 |
| Usual Care | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Month 3 | 9.3 units on a scale | Standard Deviation 6.7 |
| Usual Care | Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) | Month 6 | 9.2 units on a scale | Standard Deviation 6.2 |
Comparison: Treatment Effect - Month 3p-value: 0.66Mixed Models Analysis
Comparison: Treatment Effect - Month 6p-value: 0.18Mixed Models Analysis
Secondary
Change in Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is an eight-item questionnaire that assesses the frequency of depression and mood-related symptoms (e.g., Feeling down, depressed, or hopeless, Trouble falling or staying asleep, or sleeping too much) over the past 2 weeks. Minimum score 0. Maximum score 24. Higher scores indicate worse depression.
Time frame: Baseline, Month 3, Month 6
Population: Full sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Patient Health Questionnaire-8 (PHQ-8) | Month 3 | 9.3 score on a scale | Standard Deviation 6.5 |
| iNSPiRED | Change in Patient Health Questionnaire-8 (PHQ-8) | Baseline | 11.4 score on a scale | Standard Deviation 6.8 |
| iNSPiRED | Change in Patient Health Questionnaire-8 (PHQ-8) | Month 6 | 9.6 score on a scale | Standard Deviation 6.7 |
| Usual Care | Change in Patient Health Questionnaire-8 (PHQ-8) | Baseline | 11.8 score on a scale | Standard Deviation 6.6 |
| Usual Care | Change in Patient Health Questionnaire-8 (PHQ-8) | Month 3 | 9.7 score on a scale | Standard Deviation 6.1 |
| Usual Care | Change in Patient Health Questionnaire-8 (PHQ-8) | Month 6 | 9.6 score on a scale | Standard Deviation 6.1 |
Comparison: Treatment Effect - Month 3p-value: 0.93Mixed Models Analysis
Comparison: Treatment Effect - Month 6p-value: 0.38Mixed Models Analysis
Secondary
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, fruits and vegetable intake, fat intake, physical activity, blood-glucose testing, and foot care. and smoking. Minimum score 0. Maximum score 7 (for each area). Higher scores indicate better self care. Smoking in the last week is also assessed as a binary variable (see separate entry).
Time frame: Baseline, Month 3, Month 6
Population: Full sample.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--General Diet | 3.3 score on a scale | Standard Deviation 2.1 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Specific Diet (Fruits and Vegetables) | 2.8 score on a scale | Standard Deviation 2.2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Specific Diet (Fat) | 3.7 score on a scale | Standard Deviation 2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Physical Activity | 2.7 score on a scale | Standard Deviation 2.4 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Blood Glucose Testing | 3.0 score on a scale | Standard Deviation 2.7 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Foot Care | 4.0 score on a scale | Standard Deviation 2.2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--General Diet | 4.2 score on a scale | Standard Deviation 1.6 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Specific Diet (Fruits and Vegetables) | 3.2 score on a scale | Standard Deviation 2.2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Specific Diet (Fat) | 3.9 score on a scale | Standard Deviation 1.9 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Physical Activity | 3.3 score on a scale | Standard Deviation 2.2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Blood Glucose Testing | 3.5 score on a scale | Standard Deviation 2.6 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Foot Care | 4.3 score on a scale | Standard Deviation 2.2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--General Diet | 4.0 score on a scale | Standard Deviation 1.6 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Specific Diet (Fruits and Vegetables) | 3.2 score on a scale | Standard Deviation 2.2 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Specific Diet (Fat) | 4.0 score on a scale | Standard Deviation 1.7 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Physical Activity | 3.1 score on a scale | Standard Deviation 2.3 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Blood Glucose Testing | 3.5 score on a scale | Standard Deviation 2.6 |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Foot Care | 4.4 score on a scale | Standard Deviation 2.2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Specific Diet (Fruits and Vegetables) | 3.0 score on a scale | Standard Deviation 2.2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--General Diet | 3.3 score on a scale | Standard Deviation 2.2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Physical Activity | 2.7 score on a scale | Standard Deviation 2.2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Specific Diet (Fruits and Vegetables) | 2.8 score on a scale | Standard Deviation 2.4 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Foot Care | 3.9 score on a scale | Standard Deviation 2.4 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Specific Diet (Fat) | 3.1 score on a scale | Standard Deviation 2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Blood Glucose Testing | 3.9 score on a scale | Standard Deviation 2.6 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Physical Activity | 2.4 score on a scale | Standard Deviation 2.3 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Specific Diet (Fat) | 3.6 score on a scale | Standard Deviation 2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Blood Glucose Testing | 3.3 score on a scale | Standard Deviation 2.7 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Foot Care | 4.1 score on a scale | Standard Deviation 2.4 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Baseline--Foot Care | 3.7 score on a scale | Standard Deviation 2.5 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Blood Glucose Testing | 4.0 score on a scale | Standard Deviation 2.4 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--General Diet | 3.7 score on a scale | Standard Deviation 2.1 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--General Diet | 3.8 score on a scale | Standard Deviation 1.8 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Specific Diet (Fruits and Vegetables) | 3.1 score on a scale | Standard Deviation 2.6 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 6--Physical Activity | 2.6 score on a scale | Standard Deviation 2 |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) | Month 3--Specific Diet (Fat) | 3.8 score on a scale | Standard Deviation 2 |
Comparison: General Diet - Treatment Effect - Month 6p-value: 0.47Mixed Models Analysis
Comparison: General Diet - Treatment Effect - Month 3p-value: 0.03Mixed Models Analysis
Comparison: Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3p-value: 0.83Mixed Models Analysis
Comparison: Specific Diet (Fat) - Treatment Effect - Month 3p-value: 0.12Mixed Models Analysis
Comparison: Physical Activity - Treatment Effect - Month 3p-value: 0.17Mixed Models Analysis
Comparison: Blood Glucose Testing - Treatment Effect - Month 3p-value: 0.85Mixed Models Analysis
Comparison: Foot Care - Treatment Effect - Month 3p-value: 0.94Mixed Models Analysis
Comparison: Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6p-value: 0.82Mixed Models Analysis
Comparison: Specific Diet (Fat) - Treatment Effect - Month 6p-value: 0.66Mixed Models Analysis
Comparison: Physical Activity - Treatment Effect - Month 6p-value: 0.38Mixed Models Analysis
Comparison: Blood Glucose Testing - Treatment Effect - Month 6p-value: 0.68Mixed Models Analysis
Comparison: Foot Care - Treatment Effect - Month 6p-value: 0.4Mixed Models Analysis
Secondary
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked
The SDSCA measure is a brief self-report questionnaire of diabetes self-management. Any smoking in the last week is assessed as a binary variable. Minimum score 0 (did not smoke). Maximum score 1 (smoked). See separate entry for SDSCA items that measure the number of days per week an activity is performed. Reported counts reflect number of participants who indicated smoking in the last week.
Time frame: Baseline, Month 3, Month 6
Population: Variation in cell sizes due to missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Yes - Baseline | 23 Participants |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Yes - Month 3 | 20 Participants |
| iNSPiRED | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Yes - Month 6 | 20 Participants |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Yes - Baseline | 23 Participants |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Yes - Month 3 | 24 Participants |
| Usual Care | Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked | Yes - Month 6 | 23 Participants |
Secondary
Change in Use of Community Resources (no to Yes)
The investigators will record the Veteran's self-report of any use of community-based resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous. Yes = care in the community. No= no care in the community
Time frame: Baseline, Month 6
Population: Full sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iNSPiRED | Change in Use of Community Resources (no to Yes) | 0 participants |
| Usual Care | Change in Use of Community Resources (no to Yes) | 0 participants |
Other Pre-specified
Change in Patient Activation Measure (PAM)
The Patient Activation Measure (PAM) is designed to measure the extent to which patients endorse subjective ability to self-manage their chronic health conditions. Items assess several aspects of self-management, including knowledge (e.g., I know what each of my prescribed medications do), skill (e.g., I have been able to maintain the lifestyle changes for my health that I have made), and confidence (e.g., I am confident I can tell my health care provider concerns I have even when he or she does not ask). Raw scores: Minimum 13. Maximum 52. Scaled scores (Activation scores): Minimum 0.0. Maximum 100.0. Higher scores indicate more patient activation.
Time frame: Baseline, Month 3, Month 6
Population: Full sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Patient Activation Measure (PAM) | Baseline | 55.2 score on a scale | Standard Deviation 14.3 |
| iNSPiRED | Change in Patient Activation Measure (PAM) | Month 3 | 60.1 score on a scale | Standard Deviation 15.6 |
| iNSPiRED | Change in Patient Activation Measure (PAM) | Month 6 | 59.1 score on a scale | Standard Deviation 15.6 |
| Usual Care | Change in Patient Activation Measure (PAM) | Baseline | 53.2 score on a scale | Standard Deviation 12.7 |
| Usual Care | Change in Patient Activation Measure (PAM) | Month 3 | 56.5 score on a scale | Standard Deviation 12.4 |
| Usual Care | Change in Patient Activation Measure (PAM) | Month 6 | 56.4 score on a scale | Standard Deviation 13.5 |
Comparison: Treatment Effect - Month 3p-value: 0.38Mixed Models Analysis
Comparison: Treatment Effect - Month 6p-value: 0.68Mixed Models Analysis
Other Pre-specified
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a
PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a measures self-efficacy related to managing daily activities. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 26.02 Maximum score 59.26. Higher scores indicate higher self-efficacy.
Time frame: Baseline, Month 3, Month 6
Population: Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Baseline | 41.9 T-scores | Standard Deviation 3.2 |
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Month 3 | 42.5 T-scores | Standard Deviation 3 |
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Month 6 | 41.9 T-scores | Standard Deviation 3.3 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Baseline | 41.3 T-scores | Standard Deviation 2.9 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Month 3 | 41.8 T-scores | Standard Deviation 3.2 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a | Month 6 | 41.6 T-scores | Standard Deviation 3 |
Comparison: Treatment Effect - Month 3p-value: 0.72Mixed Models Analysis
Comparison: Treatment Effect - Month 6p-value: 0.58Mixed Models Analysis
Other Pre-specified
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a
PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a measures self-efficacy related to managing emotions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 24.82 Maximum score 63.45. Higher scores indicate higher self-efficacy.
Time frame: Baseline, Month 3, Month 6
Population: Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Baseline | 42.9 T-score | Standard Deviation 4.1 |
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Month 3 | 43.6 T-score | Standard Deviation 4.5 |
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Month 6 | 43.5 T-score | Standard Deviation 4.3 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Baseline | 43.0 T-score | Standard Deviation 4.1 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Month 3 | 43.7 T-score | Standard Deviation 4.3 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a | Month 6 | 43.5 T-score | Standard Deviation 3.9 |
Comparison: Treatment Effect - Month 3p-value: 0.74Mixed Models Analysis
Comparison: Treatment Effect - Month 6p-value: 0.62Mixed Models Analysis
Other Pre-specified
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a
PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a measures self-efficacy related to managing social interactions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 23.08 Maximum score 58.19. Higher scores indicate higher self-efficacy.
Time frame: Baseline, Month 3, Month 6
Population: Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Baseline | 39.3 T-scores | Standard Deviation 3.9 |
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Month 3 | 40.5 T-scores | Standard Deviation 3.9 |
| iNSPiRED | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Month 6 | 40.4 T-scores | Standard Deviation 3.5 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Baseline | 39.8 T-scores | Standard Deviation 4.2 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Month 3 | 40.6 T-scores | Standard Deviation 4.2 |
| Usual Care | Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a | Month 6 | 40.2 T-scores | Standard Deviation 4.2 |
Comparison: Treatment Effect - Month 3p-value: 0.5Mixed Models Analysis
Comparison: Treatment Effect - Month 6p-value: 0.18Mixed Models Analysis
Other Pre-specified
Change in Use of VHA Resources (no to Yes)
The investigators will record the Veteran's self-report of use of VHA resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous Yes = care in VHA. No= no care in VHA.
Time frame: Baseline, Month 6
Population: Full sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iNSPiRED | Change in Use of VHA Resources (no to Yes) | 0 participants |
| Usual Care | Change in Use of VHA Resources (no to Yes) | 0 participants |
Other Pre-specified
Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey
The investigators will measure engagement from the community partner perspective using the PCORI WE-ENACT Patient and Stakeholder Survey, completed annually. This measure includes items to describe engagement from the stakeholder's point of view. One or two key representatives from each community partner agency will participate. The Outcome Measure Data Table includes the number of participants who completed the survey.
Time frame: Baseline and every 12 months assessed up to month 48.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iNSPiRED | Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey | 7 Participants |
Other Pre-specified
Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey
The investigators will measure stakeholder engagement from the researcher's perspective using a modified version of the PCORI WE-ENACT Researcher Survey, completed annually. One group of researchers (the primary investigator and three team members) involved in stakeholder engagement completed the survey together at each time point. The Outcome Measure Data Table includes the number of participants who completed the survey (1 group of researchers).
Time frame: Baseline and every 12 months assessed up to month 48
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iNSPiRED | Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey | 1 Participants |