Diabetes
Conditions
Keywords
Diabetes, diabetes self-management, patient activation, social support
Brief summary
This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.
Detailed description
Background: Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources. Objectives: The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans. The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks. Methods: This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months. The intervention provides patient-supporter dyads: one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters. Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.
Interventions
OTHERCO-IMPACT
Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter
OTHERPACT
participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Provide signed and dated informed consent form * Plan to be be available for the duration of the study * Male or female, age 30-70 years old * Plan to get most diabetes care at recruiting VA primary care clinic over the subsequent 12 months * Able to use telephone to respond to bi-weekly automated Interactive Voice Response (IVR) calls * Be able to identify an adult family member or friend who is regularly involved in their health management or health care (involved with medications, managing sugars, coming to appointments, etc) * Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 outpatient encounters (OR a diabetes medication (at least one \>3 month prescription from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an assigned VAprimary care provider and at least 2 visits to VA primary care in the previous 12 months, (3) poor glycemic control (last HbA1C within 9 months \>8%) OR poor blood pressure control (last BP 160/100 or mean 6 month BP \>150/90) Care Partner Inclusion Criteria: * 21 years old or older * Fluent in English * Live in the United States
Exclusion criteria
Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Activation, as Measured by Patient Activation Measure - 13 | Baseline to 12 months | Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants |
| Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine | Baseline to 12 months | UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activation in Health Encounters | Baseline to 12 months | Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Check Feet | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Physical Activity | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Management Behavior - Healthy Eating | Baseline to 12 months | Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Glycemic Control | Baseline to 12 months | Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Systolic Blood Pressure | Baseline to 12 months | mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Distress | Baseline to 12 months | Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Non-Fasting Lipid Levels | Baseline to 12 months | Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Baseline to 12 months | Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants. |
| Change in Supporter Use of Autonomy-Supportive Communication | Baseline to 12 months | Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Smoking Status | Baseline to 12 months | Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Supporter Distress About Patient Participant's Diabetes | Baseline to 12 months | Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Diabetes Self-Efficacy | Baseline to 12 months | Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Caregiver Burden | Baseline to 12 months | Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months. |
| Change in Supporter Self-Efficacy for Helping With Diabetes Care | Baseline to 12 months | Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 11/16/16 to 5/22/18. Eligible patient participants were identified from one of two participating VHA sites. Once identified, they received an introductory letter about the study and indicated interest by phone or mail.
Pre-assignment details
None. All patient-supporter dyads who enrolled in the study were randomized to one of two study arms.
Participants by arm
| Arm | Count |
|---|---|
| CO-IMPACT patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns
CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter | 246 |
| PACT patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits | 232 |
| Total | 478 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 10 | 4 |
| Overall Study | Withdrawal by Subject | 10 | 3 |
Baseline characteristics
| Characteristic | CO-IMPACT | PACT | Total |
|---|---|---|---|
| Age, Continuous Patient Participants | 62 years | 64 years | 64 years |
| Baseline UKPDS 5-Year Cardiac Risk Score | 14.7 units on a scale STANDARD_DEVIATION 10 | 13.6 units on a scale STANDARD_DEVIATION 9.9 | 14.2 units on a scale STANDARD_DEVIATION 9.9 |
| Care Partner Lives with Patient Participant | 86 Participants | 82 Participants | 168 Participants |
| Enrolled at Hospital-based clinic (vs. community clinic site) | 78 Participants | 87 Participants | 165 Participants |
| Ethnicity (NIH/OMB) Care Partners Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Care Partners Not Hispanic or Latino | 117 Participants | 111 Participants | 228 Participants |
| Ethnicity (NIH/OMB) Care Partners Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Patient Participants Hispanic or Latino | 10 Participants | 4 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Patient Participants Not Hispanic or Latino | 112 Participants | 112 Participants | 224 Participants |
| Ethnicity (NIH/OMB) Patient Participants Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Insulin Use among Patient Participants | 78 Participants | 64 Participants | 142 Participants |
| PAM-13 Cutoff PAM-13 Prorated Score <40 | 55 Participants | 65 Participants | 120 Participants |
| PAM-13 Cutoff PAM-13 Prorated Score >40 | 68 Participants | 51 Participants | 119 Participants |
| Patient Baseline Patient Activation Measure (PAM-13) | 62.8 units on a scale STANDARD_DEVIATION 11.2 | 59.8 units on a scale STANDARD_DEVIATION 12.6 | 61.3 units on a scale STANDARD_DEVIATION 12 |
| Race (NIH/OMB) Care Partners American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Care Partners Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Care Partners Black or African American | 10 Participants | 16 Participants | 26 Participants |
| Race (NIH/OMB) Care Partners More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Care Partners Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care Partners Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Care Partners White | 103 Participants | 92 Participants | 195 Participants |
| Race (NIH/OMB) Patient Participants American Indian or Alaska Native | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Patient Participants Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient Participants Black or African American | 12 Participants | 18 Participants | 30 Participants |
| Race (NIH/OMB) Patient Participants More than one race | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Patient Participants Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Patient Participants Unknown or Not Reported | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) Patient Participants White | 90 Participants | 92 Participants | 182 Participants |
| Region of Enrollment United States | 246 Participants | 232 Participants | 478 Participants |
| Sex: Female, Male Care Partners Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Care Partners Male | 109 Participants | 106 Participants | 215 Participants |
| Sex: Female, Male Patient Participants Female | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Patient Participants Male | 117 Participants | 114 Participants | 231 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 246 | 1 / 232 |
| other Total, other adverse events | 0 / 246 | 0 / 232 |
| serious Total, serious adverse events | 29 / 246 | 2 / 232 |
Outcome results
Primary
Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine
UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine | 0.14 units on a scale | Standard Deviation 6.77 |
| PACT | Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine | -0.73 units on a scale | Standard Deviation 6.51 |
Comparison: The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.p-value: 0.3295% CI: [-0.87, 2.67]Regression, Linear
Primary
Change in Patient Activation, as Measured by Patient Activation Measure - 13
Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants
Time frame: Baseline to 12 months
Population: This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Patient Activation, as Measured by Patient Activation Measure - 13 | 2.94 units on a scale | Standard Deviation 9.86 |
| PACT | Change in Patient Activation, as Measured by Patient Activation Measure - 13 | 1.78 units on a scale | Standard Deviation 10.84 |
Comparison: The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.p-value: 0.04895% CI: [0.02, 5.18]Regression, Linear
Secondary
Change in Activation in Health Encounters
Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Activation in Health Encounters | 0.23 score on a scale | Standard Deviation 3.41 |
| PACT | Change in Activation in Health Encounters | 0.33 score on a scale | Standard Deviation 4.01 |
Comparison: The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.p-value: 0.7995% CI: [-0.71, 0.93]Regression, Linear
Secondary
Change in Diabetes Distress
Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Distress | -0.25 score on a scale | Standard Deviation 4.06 |
| PACT | Change in Diabetes Distress | -0.62 score on a scale | Standard Deviation 4.6 |
Comparison: The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.p-value: 0.8395% CI: [-0.95, 1.19]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing | 0.51 score on a scale | Standard Deviation 2.52 |
| PACT | Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing | 0.48 score on a scale | Standard Deviation 1.88 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.p-value: 0.8795% CI: [-0.76, 0.89]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing | 0.17 score on a scale | Standard Deviation 1.75 |
| PACT | Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing | 0.19 score on a scale | Standard Deviation 1.8 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.p-value: 0.3195% CI: [-0.22, 0.68]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Check Feet
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Check Feet | 0.72 score on a scale | Standard Deviation 2.06 |
| PACT | Change in Diabetes Self-Management Behavior - Check Feet | 0.72 score on a scale | Standard Deviation 2.26 |
p-value: 0.2995% CI: [-0.22, 0.75]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Healthy Eating
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Healthy Eating | 1.12 score on a scale | Standard Deviation 2.3 |
| PACT | Change in Diabetes Self-Management Behavior - Healthy Eating | 0.50 score on a scale | Standard Deviation 2.54 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.p-value: 0.0195% CI: [0.2, 1.22]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Physical Activity
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Physical Activity | 0.09 score on a scale | Standard Deviation 2.46 |
| PACT | Change in Diabetes Self-Management Behavior - Physical Activity | 0.46 score on a scale | Standard Deviation 2.13 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.p-value: 0.8795% CI: [-0.56, 0.47]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed | 0.14 score on a scale | Standard Deviation 1.34 |
| PACT | Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed | 0.48 score on a scale | Standard Deviation 2.08 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.p-value: 0.6795% CI: [-0.26, 0.41]Regression, Linear
Secondary
Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed | 0.14 score on a scale | Standard Deviation 1.17 |
| PACT | Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed | 0.23 score on a scale | Standard Deviation 1.3 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.p-value: 0.5695% CI: [-0.42, 0.23]Regression, Linear
Secondary
Change in Glycemic Control
Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Glycemic Control | -0.05 percent of glycosylated hemoglobin | Standard Deviation 1.38 |
| PACT | Change in Glycemic Control | -0.28 percent of glycosylated hemoglobin | Standard Deviation 1.43 |
Comparison: The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.p-value: 0.3395% CI: [-0.17, 0.51]Regression, Linear
Secondary
Change in Non-Fasting Lipid Levels
Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Non-Fasting Lipid Levels | -0.11 mg/dL | Standard Deviation 0.99 |
| PACT | Change in Non-Fasting Lipid Levels | -0.21 mg/dL | Standard Deviation 1.01 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.p-value: 0.2195% CI: [-0.09, 0.4]Regression, Linear
Secondary
Change in Patient Satisfaction With Healthcare System Support for Family Supporter
Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CO-IMPACT | Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Number moving from not satisfied/neither to satisfied | 35 Participants |
| CO-IMPACT | Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Those not changing or getting worse | 80 Participants |
| PACT | Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Number moving from not satisfied/neither to satisfied | 20 Participants |
| PACT | Change in Patient Satisfaction With Healthcare System Support for Family Supporter | Those not changing or getting worse | 91 Participants |
Secondary
Change in Smoking Status
Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CO-IMPACT | Change in Smoking Status | Changed from active smoker at baseline to non-smoker at 12 months | 2 Participants |
| CO-IMPACT | Change in Smoking Status | Changed from non-smoker at baseline to smoker at 12 months | 1 Participants |
| CO-IMPACT | Change in Smoking Status | No change | 112 Participants |
| PACT | Change in Smoking Status | Changed from active smoker at baseline to non-smoker at 12 months | 3 Participants |
| PACT | Change in Smoking Status | Changed from non-smoker at baseline to smoker at 12 months | 5 Participants |
| PACT | Change in Smoking Status | No change | 105 Participants |
p-value: 0.17Chi-squared
Secondary
Change in Supporter Use of Autonomy-Supportive Communication
Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Supporter Use of Autonomy-Supportive Communication | 0.27 score on a scale | Standard Deviation 0.93 |
| PACT | Change in Supporter Use of Autonomy-Supportive Communication | 0.05 score on a scale | Standard Deviation 0.94 |
Comparison: The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.p-value: 0.0195% CI: [0.08, 0.53]Regression, Linear
Secondary
Change in Systolic Blood Pressure
mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Systolic Blood Pressure | -6.41 mmHg | Standard Deviation 1.75 |
| PACT | Change in Systolic Blood Pressure | -2.46 mmHg | Standard Deviation 1.77 |
Comparison: The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.p-value: 0.1895% CI: [-7, 1.35]Regression, Linear
Other Pre-specified
Change in Caregiver Burden
Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Caregiver Burden | 0.18 score on a scale | Standard Deviation 3.77 |
| PACT | Change in Caregiver Burden | -0.54 score on a scale | Standard Deviation 3.3 |
Comparison: The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.p-value: 0.5395% CI: [-0.6, 1.16]Regression, Linear
Other Pre-specified
Change in Diabetes Self-Efficacy
Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Diabetes Self-Efficacy | 0.26 score on a scale | Standard Deviation 1.38 |
| PACT | Change in Diabetes Self-Efficacy | 0.23 score on a scale | Standard Deviation 1.48 |
Comparison: The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.p-value: 0.0195% CI: [0.09, 0.71]Regression, Linear
Other Pre-specified
Change in Supporter Distress About Patient Participant's Diabetes
Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Supporter Distress About Patient Participant's Diabetes | -0.50 score on a scale | Standard Deviation 3.57 |
| PACT | Change in Supporter Distress About Patient Participant's Diabetes | -1.08 score on a scale | Standard Deviation 3.71 |
Comparison: The null hypothesis was that change (baseline to 12 months) in PAID\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID\_CP score compared to patient participants in PACT.p-value: 0.595% CI: [-0.61, 1.25]Regression, Linear
Other Pre-specified
Change in Supporter Self-Efficacy for Helping With Diabetes Care
Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.
Time frame: Baseline to 12 months
Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO-IMPACT | Change in Supporter Self-Efficacy for Helping With Diabetes Care | 0.19 score on a scale | Standard Deviation 1.77 |
| PACT | Change in Supporter Self-Efficacy for Helping With Diabetes Care | 0.29 score on a scale | Standard Deviation 1.83 |
Comparison: The null hypothesis was that change (baseline to 12 months) in Lorig\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig\_CP score compared to patient participants in PACT.p-value: 0.6795% CI: [-0.34, 0.55]Regression, Linear