Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)

This study has been completed.
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00355147
First received: July 18, 2006
Last updated: April 6, 2015
Last verified: February 2014
Results First Received: July 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Ischemic Stroke
Transient Ischemic Attack
Interventions: Behavioral: Physician stroke guideline adherence
Behavioral: Stroke Self Management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1 Stroke Prevention Intervention Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
Arm 2 Control Group Received usual care, follow up telephone calls to control for contact, and educational materials

Participant Flow:   Overall Study
    Arm 1 Stroke Prevention Intervention     Arm 2 Control Group  
STARTED     87     87  
COMPLETED     69     67  
NOT COMPLETED     18     20  
Lost to Follow-up                 10                 8  
Withdrawal by Subject                 8                 12  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Compared groups on strata, age, sex, race/ethnicity, education level, living status, has Caregiver Number of participants were determined by protocol and followed intention to treat. For 3 and 6 month outcomes, we included respondent's last score assuming no change among those with missing data.

Reporting Groups
  Description
Arm 1 Stroke Self Management and Risk Factor Program

Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support

Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors

Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack

Attention Control Group Received Phone Calls from Staff to Control for Attention
Total Total of all reporting groups

Baseline Measures
    Arm 1 Stroke Self Management and Risk Factor Program     Attention Control Group     Total  
Number of Participants  
[units: participants]
  87     87     174  
Age  
[units: years]
Mean ± Standard Deviation
  60.4  ± 9.5     62.1  ± 9.4     61.3  ± 9.5  
Gender [1]
[units: participants]
     
Female     3     2     5  
Male     84     85     169  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     11     4     15  
Not Hispanic or Latino     76     83     159  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     1     2  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     24     29     53  
White     54     51     105  
More than one race     1     0     1  
Unknown or Not Reported     7     5     12  
Stroke Specific, Health-Related Quality of Life [2]
[units: units on a scale]
Mean ± Standard Deviation
  3.72  ± 0.68     3.92  ± 0.72     3.84  ± 0.72  
Self-Efficacy to Manage Stroke [3]
[units: units on a scale]
Mean ± Standard Deviation
  7.72  ± 1.68     8.30  ± 1.60     8.14  ± 1.60  
Self-Efficacy to Communicate with Physician [4]
[units: units on a scale]
Mean ± Standard Deviation
  2.08  ± 0.96     2.56  ± 1.28     2.32  ± 1.16  
Stroke Specific Health Related Quality of Life Perceived Energy [5]
[units: units on a scale]
Mean ± Standard Deviation
  2.62  ± 1.24     3.30  ± 1.36     3.04  ± 1.36  
Patient Health Questionnaire (PHQ)9 Depressive Symptoms [6]
[units: units on a scale]
Mean ± Standard Deviation
  7.72  ± 6.16     6.82  ± 6.68     7.00  ± 6.34  
[1] Self reported description of respondent's sex
[2] Stroke, specific, health-related quality of life (SSQoL) is a self-reported survey by LS Williams et al Stroke. 1999;30:1362-1369. Includes 12 domains and 49 items which are scored on a 5pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. Each Domain Score and the Overall Total Score all range from 1-5 with 1 being worst and 5 best best.
[3] This scale is modified from the Arthitis Self-Efficacy scale and is designed to measure Confidence to Manage Stroke Symptoms. The items measure the confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence. The scale score is the average score of the items.
[4] The scale designed by K Lorig measures the confidence to communicate with a physician about the patient's health. The response items range from 1-10 where 10 denotes a lot of confidence and a 1 denotes no confidence. The score equals the average of the items.
[5] Perceived Energy Subdomain of the Stroke Specific Quality of Life measures perceived energy after stroke. Item response is on a 5 point Likert scale where 1 denotes worse functioning and 5 denotes best functioning. Domain score was calculated as an unweighted average of item scores in the Energy subdomain.
[6] PHQ9 is a commonly used scale to measure the degree by which a respondent was bothered by depressive symptoms during the past 2 weeks by Spitzer, Williams, and Kroenke. Each of the 9 items use a 0-3 item response where 0 = "not at all" and 3 ="nearly every day." Total score is the sum of the 9 items.



  Outcome Measures
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1.  Primary:   Stroke Specific Health Related Quality of Life   [ Time Frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain ]

2.  Primary:   Self-Efficacy to Manage Stroke Symptoms   [ Time Frame: 6 months ]

3.  Secondary:   Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment   [ Time Frame: baseline, 6 months ]

4.  Secondary:   Medication (Statins) for Secondary Stroke Prevention Risk Factor Management   [ Time Frame: baseline, 6 months ]

5.  Secondary:   Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management   [ Time Frame: Baseline, 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Both our intervention and control groups experienced attrition during the study period but the rate between groups did not differ significantly.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Teresa Damush, Ph.D.
Organization: VA Stroke QUERI Center, Roudebush VAMC
phone: 317-988-4277
e-mail: Teresa.Damush@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00355147     History of Changes
Other Study ID Numbers: IAB 05-297, 0608-01B, 1009001684
Study First Received: July 18, 2006
Results First Received: July 15, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government