Trial Outcomes & Findings for Improving Health in Diabetes Project (NCT NCT02672176)

Results Overview

Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools\_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

319 participants

Primary outcome timeframe

Baseline

Results posted on

2019-10-23

Participant Flow

Participants were recruited from three Primary Care Clinics at UC Davis Health

Participant milestones

Participant milestones
Measure	Usual Care-Chronic Disease Management Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using motivational interviewing (MI), an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Overall Study STARTED	161	158
Overall Study COMPLETED	155	132
Overall Study NOT COMPLETED	6	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care-Chronic Disease Management n=155 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:	Total n=287 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=155 Participants	0 Participants n=132 Participants	0 Participants n=287 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=155 Participants	89 Participants n=132 Participants	192 Participants n=287 Participants
Age, Categorical >=65 years	52 Participants n=155 Participants	43 Participants n=132 Participants	95 Participants n=287 Participants
Age, Continuous	59.16 years STANDARD_DEVIATION 11.69 • n=155 Participants	59.59 years STANDARD_DEVIATION 11.17 • n=132 Participants	59.36 years STANDARD_DEVIATION 11.44 • n=287 Participants
Sex: Female, Male Gender · Female	73 Participants n=154 Participants • Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)	62 Participants n=130 Participants • Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)	135 Participants n=284 Participants • Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)
Sex: Female, Male Gender · Male	81 Participants n=154 Participants • Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)	68 Participants n=130 Participants • Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)	149 Participants n=284 Participants • Three participants declined to indicate gender (1 participant in the intervention group and 2 in the control group)
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=155 Participants	2 Participants n=132 Participants	3 Participants n=287 Participants
Race (NIH/OMB) Asian	16 Participants n=155 Participants	11 Participants n=132 Participants	27 Participants n=287 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=155 Participants	3 Participants n=132 Participants	5 Participants n=287 Participants
Race (NIH/OMB) Black or African American	18 Participants n=155 Participants	19 Participants n=132 Participants	37 Participants n=287 Participants
Race (NIH/OMB) White	96 Participants n=155 Participants	76 Participants n=132 Participants	172 Participants n=287 Participants
Race (NIH/OMB) More than one race	10 Participants n=155 Participants	8 Participants n=132 Participants	18 Participants n=287 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=155 Participants	13 Participants n=132 Participants	25 Participants n=287 Participants
Region of Enrollment United States	155 Participants n=155 Participants	132 Participants n=132 Participants	287 Participants n=287 Participants
Diabetes self-efficacy	3.66 units on a scale STANDARD_DEVIATION .89 • n=155 Participants	3.67 units on a scale STANDARD_DEVIATION .83 • n=132 Participants	3.66 units on a scale STANDARD_DEVIATION .85 • n=287 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Diabetes self-efficacy at baseline

Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools\_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=155 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline	3.66 Units on a scale Standard Deviation 0.89	3.67 Units on a scale Standard Deviation 0.83

PRIMARY outcome

Timeframe: 3 months

Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools\_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=153 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)	3.71 units on a scale Standard Deviation 0.86	4.05 units on a scale Standard Deviation 0.69

PRIMARY outcome

Timeframe: 9-months

Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools\_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=149 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=131 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months	3.95 units on a scale Standard Deviation 0.97	3.97 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline

Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=155 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Depression Severity Measured by PHQ-9	5.36 units on a scale Standard Deviation 4.64	5.00 units on a scale Standard Deviation 4.99

SECONDARY outcome

Timeframe: 3 months

Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=153 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Depression Severity Measured by PHQ-9	5.44 units on a scale Standard Deviation 5.24	4.19 units on a scale Standard Deviation 4.51

SECONDARY outcome

Timeframe: 9-months

Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=149 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=131 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Depression Severity Measured by PHQ-9	5.69 units on a scale Standard Deviation 6.58	4.81 units on a scale Standard Deviation 5.26

SECONDARY outcome

Timeframe: Baseline

Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=155 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Perceived Stress Measured by PSS	4.98 units on a scale Standard Deviation 3.08	5.24 units on a scale Standard Deviation 2.99

SECONDARY outcome

Timeframe: 3 months

Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=153 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Perceived Stress Measured by PSS	4.98 units on a scale Standard Deviation 2.99	4.64 units on a scale Standard Deviation 3.05

SECONDARY outcome

Timeframe: 9 months

Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=149 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=131 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
Perceived Stress Measured by PSS	5.37 units on a scale Standard Deviation 3.48	5.22 units on a scale Standard Deviation 3.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

PROMIS Emotional Distress Anxiety (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Emotional Distress Anxiety instrument measures self-reported fear, anxious misery and hyperarousal symptoms. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The four-item instrument assesses anxiety over the past seven days using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw score is translated to a T-score using a score conversion table, with a possible range of 40.3 to 81.6. A score of 50 equals the mean. Higher scores indicate greater emotional distress anxiety. This instrument has demonstrated validity and reliability with an alpha of 0.92 when evaluated in 961 in patients with chronic hepatitis C.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=155 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
PROMIS Emotional Distress Anxiety	51.96 T-score Standard Deviation 9.98	53.05 T-score Standard Deviation 10.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

PROMIS Emotional Distress Anxiety (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Emotional Distress Anxiety instrument measures self-reported fear, anxious misery and hyperarousal symptoms. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The four-item instrument assesses anxiety over the past seven days using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 40.3 to 81.6. A score of 50 equals the mean. Higher scores indicate greater emotional distress anxiety. This instrument has demonstrated validity and reliability with an alpha of 0.92 when evaluated in 961 in patients with chronic hepatitis C.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=153 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
PROMIS Emotional Distress Anxiety	49.10 T-score Standard Deviation 9.58	49.39 T-score Standard Deviation 8.88

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

PROMIS Emotional Distress Anxiety (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Emotional Distress Anxiety instrument measures self-reported fear, anxious misery and hyperarousal symptoms. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The four-item instrument assesses anxiety over the past seven days using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 40.3 to 81.6. A score of 50 equals the mean. Higher scores indicate greater emotional distress anxiety. This instrument has demonstrated validity and reliability with an alpha of 0.92 when evaluated in 961 in patients with chronic hepatitis C.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=149 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=131 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
PROMIS Emotional Distress Anxiety	51.46 T-score Standard Deviation 9.00	52.89 T-score Standard Deviation 10.64

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

PROMIS Physical Function (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Physical Function instrument assess the current physical function in the individual. It is a four-item scale measuring self-reported capability of physical activities, using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 22.5 to 57.0. A score of 50 equals the mean. Higher scores are associated with higher capability. This instrument has demonstrated validity and reliability with an alpha of 0.91 when evaluated in 4880 patients in a diverse cohort of cancer patients in the US.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=155 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
PROMIS Physical Function	30.09 T-score Standard Deviation 8.04	29.23 T-score Standard Deviation 6.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

PROMIS Physical Function (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Physical Function instrument assess the current physical function in the individual. It is a four-item scale measuring self-reported capability of physical activities, using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 22.5 to 57.0. A score of 50 equals the mean. Higher scores are associated with higher capability. This instrument has demonstrated validity and reliability with an alpha of 0.91 when evaluated in 4880 patients in a diverse cohort of cancer patients in the US.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=153 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=132 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
PROMIS Physical Function	29.79 T-score Standard Deviation 7.51	26.26 T-score Standard Deviation 6.56

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

PROMIS Physical Function (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Physical Function instrument assess the current physical function in the individual. It is a four-item scale measuring self-reported capability of physical activities, using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 22.5 to 57.0. A score of 50 equals the mean. Higher scores are associated with higher capability. This instrument has demonstrated validity and reliability with an alpha of 0.91 when evaluated in 4880 patients in a diverse cohort of cancer patients in the US.

Outcome measures

Outcome measures
Measure	Usual Care-Chronic Disease Management n=149 Participants Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals/ appointments for the patient, facilitate communication among the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis. Usual Care: This program is a well-established program within UC Davis Health, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The care coordinator assesses the needs of the patient and coordinates healthcare referrals and appointments, facilitates communication among the healthcare team, identifies health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient.	P2E2T2 Program n=131 Participants The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). P2E2T2 Program: The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
PROMIS Physical Function	29.34 T-score Standard Deviation 8.27	29.77 T-score Standard Deviation 7.28

Adverse Events

Usual Care-Chronic Disease Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P2E2T2 Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather M. Young, Principal Investigator

University of California, Davis

Phone: 916-734-4745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place