Trial Outcomes & Findings for Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life (NCT NCT01507688)

Last Updated: 2023-07-27

Results Overview

A 49-item instrument that assesses 12 domains relevant to stroke patients' health-related quality of life including: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. A lower score indicates poorer functioning and a higher score indicates better functioning. The minimum value was 1 and maximum value was 5. A Total Stroke Specific Quality of Life Score was calculated as the mean of the 49-items.

Recruitment status

COMPLETED

Study phase

Target enrollment

258 participants

Primary outcome timeframe

Change from baseline to 6 months

Results posted on

2023-07-27

Participant Flow

Recruitment period ran from Jan 7, 2013 through March 31, 2016. Recruitment sites included 2 Veterans Health Administration Medical Facilities, 1 Joint Commission Stroke Center in an urban Hospital, and 1 Safety Net Urban Hospital.

Participant milestones

Participant milestones
Measure	Arm 1 SSM Intervention Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6. Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.	Arm 2 Usual Care Usual care for treating a patient presenting with an acute ischemic stroke or TIA
Baseline to 6 Month Assessment STARTED	129	129
Baseline to 6 Month Assessment COMPLETED	113	119
Baseline to 6 Month Assessment NOT COMPLETED	16	10
6 Month to 12 Month Assessment STARTED	113	119
6 Month to 12 Month Assessment COMPLETED	108	116
6 Month to 12 Month Assessment NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SSM Intervention Arm 1 n=129 Participants Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6. Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.	Usual Care Arm 2 n=129 Participants Usual care which includes standardized patient education materials on stroke from the American Stroke Association.	Total n=258 Participants Total of all reporting groups
Age, Continuous	61.09 years STANDARD_DEVIATION 10.77 • n=5 Participants	62.41 years STANDARD_DEVIATION 10.87 • n=7 Participants	61.75 years STANDARD_DEVIATION 10.82 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	103 Participants n=7 Participants	209 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=5 Participants	127 Participants n=7 Participants	254 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	32 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	89 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	129 Participants n=5 Participants	129 Participants n=7 Participants	258 Participants n=5 Participants
Cerebrovascular Events Stroke	109 Participants n=5 Participants	109 Participants n=7 Participants	218 Participants n=5 Participants
Cerebrovascular Events Transient Ischemic Attack (TIA)	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
National Institute on Health Stroke Scale (NIHSS)	3.00 units on a scale STANDARD_DEVIATION 3.20 • n=5 Participants	2.96 units on a scale STANDARD_DEVIATION 2.81 • n=7 Participants	2.98 units on a scale STANDARD_DEVIATION 3.01 • n=5 Participants
Length of time (days)	85.74 Days n=5 Participants	77.20 Days n=7 Participants	81.47 Days n=5 Participants
Stroke Specific Quality of Life	3.06 units on a scale STANDARD_DEVIATION 0.76 • n=5 Participants	3.16 units on a scale STANDARD_DEVIATION 0.73 • n=7 Participants	3.11 units on a scale STANDARD_DEVIATION 0.75 • n=5 Participants
Self-Efficacy to Manage Stroke Symptoms	8.27 units on a scale STANDARD_DEVIATION 1.72 • n=5 Participants	8.47 units on a scale STANDARD_DEVIATION 1.55 • n=7 Participants	8.37 units on a scale STANDARD_DEVIATION 1.64 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months

Population: Participants were patients discharged with an acute stroke or TIA as the primary diagnoses.

Outcome measures

Outcome measures
Measure	Arm 1 SSM Intervention n=129 Participants Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6. Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.	Arm 2 Usual Care n=129 Participants Usual care for acute stroke care services
Total Stroke Specific Quality of Life Baseline	3.80 units on a scale Standard Deviation 0.730	3.82 units on a scale Standard Deviation 0.768
Total Stroke Specific Quality of Life 3 months outcome	4.01 units on a scale Standard Deviation 0.72	3.94 units on a scale Standard Deviation 0.79
Total Stroke Specific Quality of Life 6 months outcome	4.07 units on a scale Standard Deviation 0.75	3.95 units on a scale Standard Deviation 0.78
Total Stroke Specific Quality of Life Mean Change from 0 to 6 months	0.268 units on a scale Standard Deviation 0.06	0.133 units on a scale Standard Deviation 0.05
Total Stroke Specific Quality of Life Mean Change from 0 to 12 months	0.214 units on a scale Standard Deviation 0.04	0.181 units on a scale Standard Deviation 0.04
Total Stroke Specific Quality of Life 12 months outcome	4.02 units on a scale Standard Deviation 0.76	4.00 units on a scale Standard Deviation 0.77

Adverse Events

Arm 1 SSM Intervention

Serious events: 44 serious events

Other events: 72 other events

Deaths: 2 deaths

Arm 2 Usual Care

Serious events: 35 serious events

Other events: 61 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 SSM Intervention n=129 participants at risk Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6. Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.	Arm 2 Usual Care n=129 participants at risk Usual care for acute ischemic stroke
Vascular disorders CVD related health event	15.5% 20/129 • Number of events 44 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	6.2% 8/129 • Number of events 35 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.
Musculoskeletal and connective tissue disorders Bone fractures and strains	3.1% 4/129 • Number of events 44 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	5.4% 7/129 • Number of events 35 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.
Infections and infestations Infection	3.9% 5/129 • Number of events 44 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	2.3% 3/129 • Number of events 35 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.
Renal and urinary disorders Kidney stones	1.6% 2/129 • Number of events 44 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	0.78% 1/129 • Number of events 35 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.
General disorders General disorders	7.0% 9/129 • Number of events 44 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	10.1% 13/129 • Number of events 35 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.
General disorders Pain	3.1% 4/129 • Number of events 44 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	2.3% 3/129 • Number of events 35 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.

Other adverse events

Other adverse events
Measure	Arm 1 SSM Intervention n=129 participants at risk Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6. Stroke Self-Management: Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.	Arm 2 Usual Care n=129 participants at risk Usual care for acute ischemic stroke
General disorders General Outpatient Care	55.8% 72/129 • Number of events 72 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.	47.3% 61/129 • Number of events 61 • Adverse events were monitored and reported during each assessment period [ 3, 6, and 12 months] after baseline. Participants were asked whether they experienced an adverse or serious adverse event since last contact. If a participant was not available, the interviewer contacted the next of kin listed on the participant contact information provided and asked about adverse events. All Adverse (AE) and Serious Adverse Events (SAE) and deaths were reported to the Indiana University IRB per protocol. All were reviewed by the IRB and deemed unrelated to our research study. SAE were defined as a health event for which the participant was hospitalized for medical care. AE were defined as a health event experienced and treated by medical personnel but not hospitalized. Deaths were reported as any death occurring during the participant enrollment in the study.

Additional Information

Teresa Damush Ph.D.

VA HSRD PRIS-M QUERI and CHIC HSRD Centers

Phone: 317-988-4277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place