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Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA (CHAPS)

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ClinicalTrials.gov Identifier: NCT01532986
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Parkinson Disease
Interventions Other: Coordinated care management for Parkinson's disease
Other: Educational handout
Enrollment 345
Recruitment Details 345 participants enrolled in the study. Subjects were identified by a treating provider while receiving care at 5 Veterans Administration health systems.
Pre-assignment Details 13 removed before baseline survey. 4 were ineligible due to not having Parkinson's disease. This left 328 who were randomized
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description

Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Period Title: Overall Study
Started 166 162
Completed 143 138
Not Completed 23 24
Reason Not Completed
Death             9             9
Withdrawal by Subject             7             10
Physician Decision             7             5
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2) Total
Hide Arm/Group Description

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Total of all reporting groups
Overall Number of Baseline Participants 166 162 328
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 162 participants 328 participants
71.3  (9.2) 69.6  (10.1) 70.5  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 162 participants 328 participants
Female
2
   1.2%
7
   4.3%
9
   2.7%
Male
164
  98.8%
155
  95.7%
319
  97.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 162 participants 328 participants
African-American/Black
11
   6.6%
9
   5.6%
20
   6.1%
Asian-American
0
   0.0%
3
   1.9%
3
   0.9%
American-Indian/Alaskan Native
3
   1.8%
2
   1.2%
5
   1.5%
Caucasian/White
131
  78.9%
125
  77.2%
256
  78.0%
Hispanic/Latino
16
   9.6%
21
  13.0%
37
  11.3%
Native Hawaiian/Other Pacific Islander
3
   1.8%
0
   0.0%
3
   0.9%
More than One Race
1
   0.6%
0
   0.0%
1
   0.3%
Other
1
   0.6%
2
   1.2%
3
   0.9%
1.Primary Outcome
Title Proportion of Measures Adhered To in the PD Guidelines
Hide Description

Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data.

Range and direction of score: 0 (worst) to 1 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Deviation)
Unit of Measure: proportion of quality measures followed
0.77  (0.16) 0.58  (0.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.189
Confidence Interval (2-Sided) 95%
0.157 to 0.222
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Health Utilities Index (HUI3)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: -0.36 (worst) to 1 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.48  (0.3) 0.43  (0.3)
6 months 0.46  (0.3) 0.44  (0.3)
12 months 0.44  (0.3) 0.42  (0.3)
18 months (final) 0.40  (0.3) 0.40  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.04 to 0.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Activities of Daily Living (ADL), (Speech and Swallowing Only)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: 0 (best) to 16 (worst)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.44  (2.9) 4.68  (3.1)
6 months 4.48  (3.0) 4.75  (3.1)
12 months 4.96  (3.2) 5.06  (3.1)
18 months (final) 5.02  (3.3) 5.35  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.52 to 0.57
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Medical Outcomes Study (MOS)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: 1 (worst) to 5 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 3.91  (0.9) 4.07  (0.8)
6 months 3.93  (0.9) 3.91  (0.8)
12 months 3.91  (0.9) 4.00  (0.8)
18 months (final) 3.94  (0.9) 4.03  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.34 to 0.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title General Self-Efficacy Scale (GSES)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: 10 (worst) to 40 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 33.97  (5.1) 34.17  (5.5)
6 months 34.74  (4.9) 34.34  (5.6)
12 months 35.07  (5.1) 34.38  (5.7)
18 months (final) 35.1  (5.1) 34.04  (5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-2.04 to 0.29
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: 0 (worst) to 100 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 58.72  (33.4) 53.42  (34.9)
6 months 60.18  (32.6) 55.34  (33.6)
12 months 58.25  (34.2) 54.16  (34.5)
18 months (final) 58.55  (33.6) 53.66  (35.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
-8.02 to 10.46
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Patient Assessement of Care for Chronic Conditions (PACIC)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: 1 (worst) to 5 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Error)
Unit of Measure: units on a scale
Baselin 2.34  (0.9) 2.15  (0.8)
6 months 2.28  (0.8) 2.16  (0.7)
12 months 2.32  (0.8) 2.28  (0.8)
18 months (final) 2.37  (0.8) 2.30  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.00 to 0.34
Estimation Comments [Not Specified]
8.Secondary Outcome
Title World Health Organization Well-Being Index (WHO-5)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Range and direction of score: 1 (worst) to 25 (best)

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 14.19  (5.8) 13.14  (5.9)
6 months 15.02  (5.7) 13.93  (5.9)
12 months 14.20  (6.0) 13.38  (6.5)
18 months (final) 14.14  (6.3) 13.45  (6.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-1.45 to 1.33
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

PHQ-2 score ranges from 0 to 4. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

Higher scores indicate detection of depressive symptoms

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 166 162
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
13
   7.8%
22
  13.6%
6 months
15
   9.0%
13
   8.0%
12 months
11
   6.6%
16
   9.9%
18 months (final)
23
  13.9%
11
   6.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.52
Confidence Interval (2-Sided) 95%
-20.42 to -2.62
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Patient Healthcare Questionnaire-9 (PHQ-9)
Hide Description

Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.

Range and direction of score: 0 (best) to 27 (worst). Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.

PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2. At baseline, this was only 13 persons in usual care and 22 persons in the intervention group
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description:

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

Overall Number of Participants Analyzed 13 22
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 12.33  (4.4) 14.45  (3.9)
6 months 12.96  (4.8) 13.22  (4.2)
12 months 12.44  (4.2) 12.97  (3.6)
18 months (final) 12.21  (4.8) 12.46  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care (Arm 1), Intervention (Arm 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.98
Confidence Interval (2-Sided) 95%
-4.20 to 0.24
Estimation Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description Because this is a care intervention to promote best practices, we do not believe that deaths observed to this study should be considered adverse events of the study.
 
Arm/Group Title Usual Care (Arm 1) Intervention (Arm 2)
Hide Arm/Group Description

Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.

Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook.

All-Cause Mortality
Usual Care (Arm 1) Intervention (Arm 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/166 (5.42%)   9/162 (5.56%) 
Hide Serious Adverse Events
Usual Care (Arm 1) Intervention (Arm 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/166 (0.00%)   0/162 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care (Arm 1) Intervention (Arm 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/166 (0.00%)   0/162 (0.00%) 
Study implemented within the Veterans Administration
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric M Cheng
Organization: VA Greater Los Angeles Healthcare System
Phone: 3102067671
EMail: echeng@mednet.ucla.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01532986    
Other Study ID Numbers: NRI 11-126
First Submitted: January 13, 2012
First Posted: February 15, 2012
Results First Submitted: March 16, 2018
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019