VHPI: Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01566214
• Collaborator: University of Iowa (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes. From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Behavioral: Motivational Interview	Phase 2

Detailed Description

Coronary heart disease (CHD) is a significant health threat among veterans. Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS). High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality. The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS. The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity). The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality. The proposed project is the requisite next step in attaining that goal.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Representational Telehealth Nursing Intervention for Veterans With CHD
• Actual Study Start Date: Apr 30, 2012
• Actual Primary Completion Date: Jun 30, 2012
• Actual Study Completion Date: Oct 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interview For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	Behavioral: Motivational Interview; For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
No Intervention: Usual Care For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.

Outcome Measures

Primary Outcome Measures

1. SF-36v Physical Function Scale [Change from baseline to 3-months post hospital discharge]

   Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

2. SF-36v Role Limitations Due to Physical Health Scale [Change from baseline to 3-months post hospital discharge]

   Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

3. SF-36v Role Limitations Due to Emotional Problems Scale [Change from baseline to 3-months post hospital discharge]

   Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

4. SF-36v Energy-Fatigue Scale [Change from baseline to 3-months post hospital discharge]

   Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

5. SF-36v Emotional Well-Being Scale [Change from baseline to 3-months post hospital discharge]

   Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

6. SF-36v Social Functioning Scale [Change from baseline to 3-months post hospital discharge]

   Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

7. SF-36v Pain Scale [Change from baseline to 3-months post hospital discharge]

   Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

8. SF-36v General Health Scale [Change from baseline to 3-months post hospital discharge]

   General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

9. Seattle Angina Questionnaire Physical Limitations Scale [Change from baseline to 3-months post hospital discharge]

   Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

10. Seattle Angina Questionnaire Angina Stability Scale [Change from baseline to 3-months post hospital discharge]

    Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

11. Seattle Angina Questionnaire Angina Frequency Scale [Change from baseline to 3-months post hospital discharge]

    Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

12. Seattle Angina Questionnaire Treatment Satisfaction Scale [Change from baseline to 3-months post hospital discharge]

    Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

13. Seattle Angina Questionnaire Disease Perception Scale [Change from baseline to 3-months post hospital discharge]

    Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Admission to an inpatient medicine unit for MI, ACS, and coronary angiography

• Age

Exclusion Criteria:

• Altered mental status

• Language barriers

• Dementia or Cognitive Impairment

• Diagnostic Study

• Resident in long-term care facility prior to the present admission

• Planned discharge to a skilled or intermediate care facility or hospice

• Lack of access to a functioning phone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa	United States	52246-2208

Sponsors and Collaborators

• VA Office of Research and Development
• University of Iowa

Investigators

• Principal Investigator: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01566214
• Other Study ID Numbers: PPO 09-283; 200910778
• First Posted: Mar 29, 2012
• Last Update Posted: Dec 24, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by VA Office of Research and Development: coronary heart disease (CHD); myocardial infarction (MI); acute coronary syndromes (ACS)
• Additional relevant MeSH terms: Heart Diseases

Study Results

Participant Flow

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Period Title: Overall Study
STARTED	6	6
COMPLETED	3	6
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Motivational Interview	Usual Care	Total
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.	Total of all reporting groups
Overall Participants	6	6	12
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.33 (11.98)	65.67 (8.64)	67.00 (10.05)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	6 100%	6 100%	12 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	3 50%	1 16.7%	4 33.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 50%	5 83.3%	8 66.7%
Region of Enrollment (participants) [Number]
United States	6 100%	6 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	SF-36v Physical Function Scale
Description	Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

Participants who completed the SF-36v at baseline, 1 month, and 3 months.

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-6.67 (7.64)	13.33 (12.52)

2. Primary Outcome

Title	SF-36v Role Limitations Due to Physical Health Scale
Description	Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-22.92 (35.54)	9.38 (36.39)

3. Primary Outcome

Title	SF-36v Role Limitations Due to Emotional Problems Scale
Description	Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-27.78 (25.46)	5.56 (13.61)

4. Primary Outcome

Title	SF-36v Energy-Fatigue Scale
Description	Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-5.00 (42.65)	1.67 (23.49)

5. Primary Outcome

Title	SF-36v Emotional Well-Being Scale
Description	Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-14.67 (37.86)	-2.00 (7.90)

6. Primary Outcome

Title	SF-36v Social Functioning Scale
Description	Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-16.67 (40.18)	-10.42 (18.40)

7. Primary Outcome

Title	SF-36v Pain Scale
Description	Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-5.00 (13.23)	14.17 (13.10)

8. Primary Outcome

Title	SF-36v General Health Scale
Description	General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-5.00 (18.03)	4.17 (17.15)

9. Primary Outcome

Title	Seattle Angina Questionnaire Physical Limitations Scale
Description	Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-5.93 (8.98)	3.33 (30.43)

10. Primary Outcome

Title	Seattle Angina Questionnaire Angina Stability Scale
Description	Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

Note that because 4 participants in the Usual Care group reported that they did not experience chest pain in the prior four weeks, their responses could not be included in the analysis, as the scale measures changes in the severity of chest pain. Therefore, only 2 participants in the Usual Care group contributed to the analysis.

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	2
Mean (Standard Deviation) [units on a scale]	25.00 (66.14)	-12.50 (17.68)

11. Primary Outcome

Title	Seattle Angina Questionnaire Angina Frequency Scale
Description	Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	20.00 (43.59)	16.67 (22.51)

12. Primary Outcome

Title	Seattle Angina Questionnaire Treatment Satisfaction Scale
Description	Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	-3.92 (33.45)	7.84 (10.95)

13. Primary Outcome

Title	Seattle Angina Questionnaire Disease Perception Scale
Description	Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time Frame	Change from baseline to 3-months post hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Motivational Interview	Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.	For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
Measure Participants	3	6
Mean (Standard Deviation) [units on a scale]	13.89 (9.62)	9.72 (17.01)

Adverse Events

Time Frame	3 Months
Arm/Group Title	Motivational Interview		Usual Care
Arm/Group Description	For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.		For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
All Cause Mortality
	Motivational Interview		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Motivational Interview		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Motivational Interview		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.