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Will Veterans Engage in Prevention After HRA-guided Shared Decision Making? (ACTIVATE)

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ClinicalTrials.gov Identifier: NCT01828567
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Health Risk Appraisal
Heart Disease
Prevention
Intervention Behavioral: Shared decision making with a Prevention Coach
Enrollment 417
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
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Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Period Title: Overall Study
Started 208 209
1 Month 172 192
Completed 177 199
Not Completed 31 10
Reason Not Completed
Lost to Follow-up             27             9
Excluded - did not meet criteria             4             1
Arm/Group Title Intervention Control Total
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Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care Total of all reporting groups
Overall Number of Baseline Participants 208 209 417
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 208 participants 209 participants 417 participants
55.3  (12.7) 56.3  (11.7) 55.8  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 209 participants 417 participants
Female
36
  17.3%
25
  12.0%
61
  14.6%
Male
172
  82.7%
184
  88.0%
356
  85.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 209 participants 417 participants
Black or African American
90
  43.3%
79
  37.8%
169
  40.5%
White
99
  47.6%
110
  52.6%
209
  50.1%
Other
19
   9.1%
20
   9.6%
39
   9.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 208 participants 209 participants 417 participants
208
 100.0%
209
 100.0%
417
 100.0%
1.Primary Outcome
Title Enrollment in Prevention Services
Hide Description Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.
Time Frame 1 and 6 months (cumulative)
Hide Outcome Measure Data
Hide Analysis Population Description
Unknowns were removed from the denominator: Intervention n=29; control n=15.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Overall Number of Participants Analyzed 179 194
Measure Type: Number
Unit of Measure: participants
91 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.
Type of Statistical Test Other
Comments A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.54
Confidence Interval (2-Sided) 95%
1.66 to 3.89
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Patient Activation Measures (PAM)
Hide Description Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
Time Frame Baseline assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Overall Number of Participants Analyzed 208 209
Mean (Standard Deviation)
Unit of Measure: average score
62.4  (12.7) 60.6  (12.3)
3.Secondary Outcome
Title Patient Activation Measures
Hide Description Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
Time Frame 1 month assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Overall Number of Participants Analyzed 172 192
Mean (Standard Deviation)
Unit of Measure: average score
63.7  (13.8) 61.4  (11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.
Method Repeated Measures
Comments This model assumes the groups have equal baseline means.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-0.8 to 3.7
Estimation Comments We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.
4.Secondary Outcome
Title Patient Activation Measures
Hide Description Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant
Time Frame 6 months assessments
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Overall Number of Participants Analyzed 177 199
Mean (Standard Deviation)
Unit of Measure: average score
67.0  (13.0) 63.2  (13.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.
Statistical Test of Hypothesis P-Value 0.030
Comments A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.
Method Repeated Measures
Comments This model assumes the groups have equal baseline means.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
0.2 to 4.7
Estimation Comments We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.
5.Secondary Outcome
Title Framingham Risk Score
Hide Description The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Unknowns were removed from the denominator: Intervention n=7; control n=2.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Overall Number of Participants Analyzed 201 207
Mean (Standard Deviation)
Unit of Measure: average score
21.8  (16.8) 22.7  (16.8)
6.Secondary Outcome
Title Framingham Risk Score
Hide Description The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Unknowns were removed from the denominator: Intervention n=22; control n=18.
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
Overall Number of Participants Analyzed 155 181
Mean (Standard Deviation)
Unit of Measure: average score
22.4  (17.5) 22.5  (16.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.
Type of Statistical Test Equivalence
Comments This model assumes the groups have equal baseline means
Statistical Test of Hypothesis P-Value 0.330
Comments [Not Specified]
Method Repeated Measures
Comments A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.7 to 2.2
Estimation Comments We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.
Time Frame Through study completion, an average of 6 months.
Adverse Event Reporting Description Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment

Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.

Usual care
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/208 (31.25%)      53/209 (25.36%)    
Blood and lymphatic system disorders     
Study Safety Protocol *  1/208 (0.48%)  1 0/209 (0.00%)  0
Hospitalization *  0/208 (0.00%)  0 2/209 (0.96%)  2
Cardiac disorders     
Study Safety Protocol *  4/208 (1.92%)  4 2/209 (0.96%)  2
Hospitalization *  2/208 (0.96%)  2 0/209 (0.00%)  0
Important Medical Event *  1/208 (0.48%)  1 0/209 (0.00%)  0
Endocrine disorders     
Hospitalization *  0/208 (0.00%)  0 1/209 (0.48%)  1
Gastrointestinal disorders     
Hospitalization *  0/208 (0.00%)  0 1/209 (0.48%)  1
General disorders     
Hospitalization *  1/208 (0.48%)  1 0/209 (0.00%)  0
Hepatobiliary disorders     
Hospitalization *  2/208 (0.96%)  2 0/209 (0.00%)  0
Investigations     
Protocol Deviation *  45/208 (21.63%)  45 36/209 (17.22%)  36
Musculoskeletal and connective tissue disorders     
Hospitalization *  1/208 (0.48%)  1 1/209 (0.48%)  1
Emergency Room Visit *  0/208 (0.00%)  0 3/209 (1.44%)  3
Important Medical Event *  1/208 (0.48%)  1 3/209 (1.44%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Important Medical Event *  2/208 (0.96%)  2 1/209 (0.48%)  1
Psychiatric disorders     
Hospitalization *  5/208 (2.40%)  5 2/209 (0.96%)  2
Important Medical Event *  1/208 (0.48%)  1 0/209 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Emergency Room Visit *  1/208 (0.48%)  1 0/209 (0.00%)  0
Hospitalization *  2/208 (0.96%)  2 3/209 (1.44%)  3
Important Medical Event *  1/208 (0.48%)  1 0/209 (0.00%)  0
Surgical and medical procedures     
Hospitalization *  1/208 (0.48%)  1 1/209 (0.48%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/208 (0.00%)      0/209 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Eugene Z Oddone, MD, MPSc
Organization: Durham VA Center of Innovation in Primary Care
Phone: 919-286-0411
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01828567     History of Changes
Other Study ID Numbers: CRE 12-288
First Submitted: April 5, 2013
First Posted: April 10, 2013
Results First Submitted: December 19, 2017
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018