Trial Outcomes & Findings for Adapting Tools to Implement Stroke Risk Management to Veterans (NCT NCT00355147)

Last Updated: 2018-10-11

Results Overview

* Stroke Specifc, Health Related Quality of Life (SSQoL) * Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369. * Contains 12 domains and 49 items Scored on a 5 pt 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. We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05.

Recruitment status

COMPLETED

Study phase

Target enrollment

174 participants

Primary outcome timeframe

6 months for (SSQoL) and 3 months for Perceived Energy Subdomain

Results posted on

2018-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	87	87
Overall Study COMPLETED	69	67
Overall Study NOT COMPLETED	18	20

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	10	8
Overall Study Withdrawal by Subject	8	12

Baseline Characteristics

Adapting Tools to Implement Stroke Risk Management to Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Stroke Self Management and Risk Factor Program n=87 Participants 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 n=87 Participants Received Phone Calls from Staff to Control for Attention	Total n=174 Participants Total of all reporting groups
Patient Health Questionnaire (PHQ)9 Depressive Symptoms	7.72 units on a scale STANDARD_DEVIATION 6.16 • n=5 Participants	6.82 units on a scale STANDARD_DEVIATION 6.68 • n=7 Participants	7.00 units on a scale STANDARD_DEVIATION 6.34 • n=5 Participants
Stroke Specific Health Related Quality of Life Perceived Energy	2.62 units on a scale STANDARD_DEVIATION 1.24 • n=5 Participants	3.30 units on a scale STANDARD_DEVIATION 1.36 • n=7 Participants	3.04 units on a scale STANDARD_DEVIATION 1.36 • n=5 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 9.5 • n=5 Participants	62.1 years STANDARD_DEVIATION 9.4 • n=7 Participants	61.3 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	85 Participants n=7 Participants	169 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	83 Participants n=7 Participants	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	51 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Stroke Specific, Health-Related Quality of Life	3.72 units on a scale STANDARD_DEVIATION 0.68 • n=5 Participants	3.92 units on a scale STANDARD_DEVIATION 0.72 • n=7 Participants	3.84 units on a scale STANDARD_DEVIATION 0.72 • n=5 Participants
Self-Efficacy to Manage Stroke	7.72 units on a scale STANDARD_DEVIATION 1.68 • n=5 Participants	8.30 units on a scale STANDARD_DEVIATION 1.60 • n=7 Participants	8.14 units on a scale STANDARD_DEVIATION 1.60 • n=5 Participants
Self-Efficacy to Communicate with Physician	2.08 units on a scale STANDARD_DEVIATION 0.96 • n=5 Participants	2.56 units on a scale STANDARD_DEVIATION 1.28 • n=7 Participants	2.32 units on a scale STANDARD_DEVIATION 1.16 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain

Population: We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, and time.

Outcome measures

Outcome measures
Measure	Arm 1 Stroke Self Management and Risk Factor Program n=71 Participants 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/TIA	Attention Control Group n=68 Participants Received Phone Calls from Staff to Control for Attention
Stroke Specific Health Related Quality of Life Overall Total Score	3.80 units on a scale Standard Deviation 0.90	3.94 units on a scale Standard Deviation 0.82
Stroke Specific Health Related Quality of Life Perceived Energy Score	2.98 units on a scale Standard Deviation 1.56	3.04 units on a scale Standard Deviation 1.42

PRIMARY outcome

Timeframe: 6 months

Population: We hypothesized the intervention group would report significantly greater self-efficacy to manage stroke symptoms than the control group. Level of significance was set to .05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, \& time.

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.

Outcome measures

Outcome measures
Measure	Arm 1 Stroke Self Management and Risk Factor Program n=60 Participants 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/TIA	Attention Control Group n=63 Participants Received Phone Calls from Staff to Control for Attention
Self-Efficacy to Manage Stroke Symptoms	7.90 units on a scale Standard Deviation 1.78	8.08 units on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: baseline, 6 months

Population: We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.

* Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data * Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%) * Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%

Outcome measures

Outcome measures
Measure	Arm 1 Stroke Self Management and Risk Factor Program n=32 Participants 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/TIA	Attention Control Group n=14 Participants Received Phone Calls from Staff to Control for Attention
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment >=80% Compliance at baseline	13 participants	8 participants
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment <80% Compliance at baseline	19 participants	6 participants
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment >=80% Compliance at 6 months	21 participants	6 participants
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment <80% Compliance at 6 months	11 participants	8 participants

SECONDARY outcome

Timeframe: baseline, 6 months

* Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data * Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%). * Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%.

Outcome measures

Outcome measures
Measure	Arm 1 Stroke Self Management and Risk Factor Program n=72 Participants 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/TIA	Attention Control Group n=71 Participants Received Phone Calls from Staff to Control for Attention
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management >=80% Compliance at baseline	16 participants	18 participants
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management <80% Compliance at baseline	56 participants	53 participants
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management >=80% Compliance at 6 months	44 participants	39 participants
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management <80% Compliance at 6 months	28 participants	32 participants

SECONDARY outcome

Timeframe: Baseline, 6 months

* Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data * Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%) * Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%.

Outcome measures

Outcome measures
Measure	Arm 1 Stroke Self Management and Risk Factor Program n=79 Participants 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/TIA	Attention Control Group n=70 Participants Received Phone Calls from Staff to Control for Attention
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management >=80% Compliance at baseline	39 participants	41 participants
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management <80% Compliance at baseline	40 participants	29 participants
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management >=80% Compliance at 6 months	61 participants	48 participants
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management <80% Compliance at 6 months	18 participants	22 participants

Adverse Events

Arm 1 Stroke Self Management and Risk Factor Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Teresa Damush, Ph.D.

VA Stroke QUERI Center, Roudebush VAMC

Phone: 317-988-4277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place