Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Activity Behavior Change for Older Adults After Dysvascular Amputation (PABC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738086
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Amputation
Diabetes Mellitus, Type 2
Peripheral Artery Disease
Intervention Behavioral: Physical Activity Behavior Change (PABC)
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early PABC Intervention (Months 1-3) Wait-List Control Intervention (Months 4-6)
Hide Arm/Group Description

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Period Title: Overall Study
Started 16 15
Completed 14 13
Not Completed 2 2
Arm/Group Title Early PABC Intervention Wait-List Control Intervention Total
Hide Arm/Group Description

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
67.9  (6.2) 63.4  (8.9) 65.7  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
16
 100.0%
15
 100.0%
31
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Hispanic or Latino
1
   6.3%
2
  13.3%
3
   9.7%
Not Hispanic or Latino
15
  93.8%
13
  86.7%
28
  90.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
American Indian or Alaska Native
1
   6.3%
1
   6.7%
2
   6.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  18.8%
0
   0.0%
3
   9.7%
White
12
  75.0%
14
  93.3%
26
  83.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 31 participants
16
 100.0%
15
 100.0%
31
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants 15 participants 31 participants
27  (5) 31  (6) 29  (6)
Time Since Amputation (months)  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 16 participants 15 participants 31 participants
37  (41) 36  (16) 36  (31)
Level of Amputation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Transtibial
14
  87.5%
12
  80.0%
26
  83.9%
Transfemoral
2
  12.5%
3
  20.0%
5
  16.1%
Geriatric Depression Scale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 15 participants 31 participants
4.1  (4.0) 3.7  (3.8) 3.9  (3.9)
[1]
Measure Description: Scores are on a scale of 0 to 15, with scores of 0 to 5 being normal. A score greater than 5 suggests depression.
Mini-Mental Status Examination score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 15 participants 31 participants
28.4  (4.5) 29.0  (1.6) 28.7  (3.1)
[1]
Measure Description: Scores range from 0 to 30 with scores above 24 indicating normal cognition.
Chakrabarty Grade score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 15 participants 31 participants
84.8  (18.4) 85.7  (12.4) 85.2  (15.4)
[1]
Measure Description: Scoring system of residual-limb quality. Scores can range from -115 to 100. Higher scores indicate better residual limb quality.
Functional Comorbidity Index score   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of Comorbidities
Number Analyzed 16 participants 15 participants 31 participants
6.8  (3.3) 6.0  (3.2) 6.4  (3.3)
[1]
Measure Description: Scores can be between 0 and 18. Higher scores indicate a larger number of comorbidities.
1.Primary Outcome
Title Retention Rate
Hide Description Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
14
  87.5%
13
  86.7%
2.Primary Outcome
Title Dose Goal Attainment
Hide Description Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PABC Intervention
Hide Arm/Group Description:

Groups 1 and 2

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.3%
3.Primary Outcome
Title Acceptability
Hide Description Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PABC Intervention
Hide Arm/Group Description:

Groups 1 and 2

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.8  (0.8)
4.Primary Outcome
Title Study-Related Adverse Events
Hide Description Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 16 15
Measure Type: Number
Unit of Measure: Adverse Events
20 29
5.Secondary Outcome
Title Accelerometer-Based Physical Activity
Hide Description Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: Steps
1609
(826 to 2393)
1897
(1242 to 2551)
6.Secondary Outcome
Title Late Life Function and Disability Scale, Frequency
Hide Description The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
49.3
(46.2 to 52.4)
54.5
(48.5 to 60.6)
7.Secondary Outcome
Title Accelerometer-Based Physical Activity
Hide Description Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: Steps
1716
(948 to 2483)
1773
(1189 to 2357)
8.Secondary Outcome
Title Late Life Function and Disability Scale, Frequency
Hide Description The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
52.5
(48.6 to 56.3)
51.3
(48.4 to 54.3)
9.Secondary Outcome
Title Late Life Function and Disability Scale, Limitation
Hide Description The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
71.4
(63.2 to 79.7)
68.1
(55.3 to 80.9)
10.Secondary Outcome
Title Late Life Function and Disability Scale, Limitation
Hide Description The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early PABC Intervention GROUP 2: Wait-List Control Intervention
Hide Arm/Group Description:

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

Overall Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
74.3
(65.3 to 83.3)
68.6
(60.7 to 76.4)
Time Frame For Group 1 adverse event data were collected weekly during the 12 week intervention, and at 24 weeks. For Group 2 adverse event data were collected weekly during the 12 week attention control period and weekly during the 12 week intervention.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GROUP 1: Early PABC Intervention (Months 1-3) GROUP 1: No Contact Phase (Months 4-6) GROUP 2: PABC Attention Control (Months 1-3) GROUP 2: PABC Intervention (Months 4-6)
Hide Arm/Group Description

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months. GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months.

Physical Activity Behavior Change (PABC): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.

All-Cause Mortality
GROUP 1: Early PABC Intervention (Months 1-3) GROUP 1: No Contact Phase (Months 4-6) GROUP 2: PABC Attention Control (Months 1-3) GROUP 2: PABC Intervention (Months 4-6)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
GROUP 1: Early PABC Intervention (Months 1-3) GROUP 1: No Contact Phase (Months 4-6) GROUP 2: PABC Attention Control (Months 1-3) GROUP 2: PABC Intervention (Months 4-6)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      2/16 (12.50%)      1/15 (6.67%)      0/15 (0.00%)    
Cardiac disorders         
Cardiac Disorder - Other  1  1/16 (6.25%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Psychiatric disorders         
Suicidal Ideation  1  0/16 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders         
Non-Healing Wounds  1  0/16 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GROUP 1: Early PABC Intervention (Months 1-3) GROUP 1: No Contact Phase (Months 4-6) GROUP 2: PABC Attention Control (Months 1-3) GROUP 2: PABC Intervention (Months 4-6)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/16 (50.00%)      5/16 (31.25%)      8/15 (53.33%)      7/15 (46.67%)    
Injury, poisoning and procedural complications         
Fall  1  4/16 (25.00%)  4 2/16 (12.50%)  2 5/15 (33.33%)  5 3/15 (20.00%)  3
Skin and subcutaneous tissue disorders         
Wound  1  7/16 (43.75%)  8 3/16 (18.75%)  3 5/15 (33.33%)  5 6/15 (40.00%)  6
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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: Cory L. Christiansen
Organization: University of Colorado Denver
Phone: 303-724-9101
EMail: cory.christiansen@cuanschutz.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02738086    
Other Study ID Numbers: F2054-P
First Submitted: March 16, 2016
First Posted: April 14, 2016
Results First Submitted: January 10, 2020
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020