Trial Outcomes & Findings for Mindfulness After Stroke (NCT NCT04553679)

Last Updated: 2023-02-22

Results Overview

Quality of life and impact of stroke after the intervention. The Stroke Impact Scale is a 59-item measure and is divided in 8 domains. Scores range from 0-100 (with higher score showing better quality of life and lower stroke impact).

Recruitment status

COMPLETED

Target enrollment

16 participants

Primary outcome timeframe

from baseline to 3 weeks

Results posted on

2023-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Stroke Survivors Participants who have had a stroke	Caregivers Participants caring for someone who have had a stroke
Overall Study STARTED	13	3
Overall Study COMPLETED	11	2
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Stroke Survivors Participants who have had a stroke	Caregivers Participants caring for someone who have had a stroke
Overall Study Withdrawal by Subject	2	0
Overall Study Caregiver only took part in the qualitative interview (no quantitative outcomes)	0	1

Baseline Characteristics

One participant in the caregiver group did not receive the intervention, but participated to the qualitative interview to provide feedback about the program.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stroke Survivors n=13 Participants Participants who have had a stroke	Caregivers n=3 Participants Participants who care for someone who have had a stroke	Total n=16 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 12.1 • n=5 Participants • One participant in the caregiver group did not receive the intervention, but participated to the qualitative interview to provide feedback about the program.	59.7 years STANDARD_DEVIATION 21.5 • n=7 Participants • One participant in the caregiver group did not receive the intervention, but participated to the qualitative interview to provide feedback about the program.	64.1 years STANDARD_DEVIATION 13.6 • n=5 Participants • One participant in the caregiver group did not receive the intervention, but participated to the qualitative interview to provide feedback about the program.
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	3 Participants n=7 Participants	15 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	1 Participants n=7 Participants	9 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to 3 weeks

Population: The Stroke Impact Scale is a measure of stroke severity. It was not administered to caregivers. Two stroke survivors did not complete the post-intervention measurement.

Outcome measures

Outcome measures
Measure	Stroke Survivors n=11 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers Participants who care for someone who have had a stroke
Change in Stroke Impact Scale	2.3 score on a scale Standard Deviation 24.3	—

SECONDARY outcome

Timeframe: from baseline to 3 weeks

Population: Two stroke survivors did not complete the post-intervention measurement. One caregiver group did not receive the intervention (only did the qualitative portion of the study).

The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with 7 items each for anxiety and depression subscales. Each item is scored from 0 to 3, with higher scores indicating higher anxiety or depressive symptoms. Anxiety and depression with scores ranging from 0 (no depression/anxiety) to 21 (severe depressive/anxious symptoms).

Outcome measures

Outcome measures
Measure	Stroke Survivors n=11 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers n=2 Participants Participants who care for someone who have had a stroke
Change in Hospital Anxiety and Depression Scale	0.9 score on a scale Standard Deviation 3.5	5 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: from baseline to 3 weeks

Population: Two stroke survivors did not complete the post-intervention measurement. One caregiver group did not receive the intervention (only did the qualitative portion of the study).

10-item self-reported measure assessing perceived stress. Scores range from 10 to 50, with higher scores indicating greater levels of perceived stress.

Outcome measures

Outcome measures
Measure	Stroke Survivors n=11 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers n=2 Participants Participants who care for someone who have had a stroke
Change in National Institute of Health Perceived Stress Survey	1.1 score on a scale Standard Deviation 5.1	4.5 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: from baseline to 3 weeks

Population: Two stroke survivors did not complete the post-intervention measurement. One caregiver group did not receive the intervention (only did the qualitative portion of the study).

1-item sleep quality scale ranging from 1 to 10. Higher scores indicate better sleep quality.

Outcome measures

Outcome measures
Measure	Stroke Survivors n=11 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers n=2 Participants Participants who care for someone who have had a stroke
Change in Single-Item Sleep Quality Scale	0.9 units on a scale Standard Deviation 2.1	4 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: from baseline to 3 weeks

Population: One caregiver group did not receive the intervention (only did the qualitative portion of the study).

The World Health Organization Quality of Life-BREF (WHOQOL-BREF) comprises 26 questions from 4 domains about health and well-being: 1) Physical health (e.g., Activities of daily living, Mobility, Fatigue, etc.), 2) Psychological (e.g., Negative/positive feelings, Self-esteem, Spirituality, etc.), 3) Social relationships (e.g., Personal relationships, Social support, Sexual activity), 4) Environment (e.g., financial resources, home environment, opportunities for leisures, etc.). The scores are transformed on a scale from 0-100. Higher scores indicate better perceived health and well-being. Outcome measure only administered to caregivers.

Outcome measures

Outcome measures
Measure	Stroke Survivors n=2 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers Participants who care for someone who have had a stroke
Change in World Health Organization Quality of Life-bref	6.25 score on a scale Standard Deviation 4.7	—

SECONDARY outcome

Timeframe: 3 weeks

Population: Two stroke survivors did not complete the post-intervention measurement. One caregiver group did not receive the intervention (only did the qualitative portion of the study).

The adapted Post-Study System Usability Questionnaire (PSSUQ) consists of 5 questions on perceived satisfaction with the online platform used to host the program. Each question is scored on a 7-point Likert scale from 1 (Strongly Agree) to 7 (Strongly Disagree) for a total score of 35. Higher scores indicate lower usability.

Outcome measures

Outcome measures
Measure	Stroke Survivors n=11 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers n=2 Participants Participants who care for someone who have had a stroke
Adapted Post-Study System Usability Questionnaire	14.3 score on a scale Standard Deviation 7.9	24.5 score on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: from baseline to 3 weeks

Population: One caregiver group did not receive the intervention (only did the qualitative portion of the study).

The Zarit Burden Interview includes 22 questions about caregiver burden rated from 0 (never) to 4 (nearly always). Scores range from 0-88 with higher scores indicating greater burden. Measure administered only to participants in the caregiver group.

Outcome measures

Outcome measures
Measure	Stroke Survivors n=2 Participants Participants who have had a stroke Mindfulness online intervention: A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.	Caregivers Participants who care for someone who have had a stroke
Change in Zarit Burden Interview	3 score on a scale Standard Deviation 9.9	—

Adverse Events

Stroke Survivors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caregivers

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stroke Survivors n=13 participants at risk Participants who have had a stroke	Caregivers n=3 participants at risk Participants caring for someone who have had a stroke
Musculoskeletal and connective tissue disorders Moderate Adverse Event (Shoulder pain)	0.00% 0/13 • Adverse events were collected for the duration of the study period (up to 1 month post-intervention). The clinicaltrials.gov definition was used.	33.3% 1/3 • Number of events 1 • Adverse events were collected for the duration of the study period (up to 1 month post-intervention). The clinicaltrials.gov definition was used.

Additional Information

Marika Demers, PhD, OT, post-doctoral research fellow

University of Southern California

Phone: 13234421196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place