Caregiver Burden, Stroke
Conditions
Keywords
Mindfulness, Rehabilitation, Caregiver, Attention to variability
Brief summary
The purpose of this study is to test the relevance, satisfaction and ease-of-use of an online mindfulness intervention among stroke survivors and their caregivers. Quality of life, depression, anxiety, stress and sleep quality will be assessed before, after and at 1 month after the intervention. After the intervention, participants' feedback about the usability and the satisfaction with the intervention and the online program will be gathered. Based on participants' feedback, changes to the intervention will be made to obtain a final version.
Detailed description
The incidence of depression and anxiety is much higher in stroke survivors and their caregivers compared to age-matched peers. Previous work suggests that mindfulness delivered in an online format is promising for both individuals with neurological disorders and caregivers to improve quality of life and psychological well-being. The overall objective of this project is to develop and refine an online mindfulness program that is perceived as relevant and user-friendly for stroke survivors and their caregivers. This project also aims to determine the potential impact of the mindfulness program on psychological well-being for stroke survivors and caregivers to guide the development of a future intervention study. The process of development of the online mindfulness program will be iterative and will involve three phases: one development phase, one usability testing phase with end-users and one refinement phase. Phase 1) The 3-week online mindfulness program will be adapted from the program developed for individuals with amyotrophic lateral sclerosis by mindfulness and stroke experts to ensure suitability and relevance for individuals with stroke. Phase 2) A testing phase will be conducted remotely for both technical and clinical verification with 5-10 stroke survivors and 5-10 caregivers. Self-reported questionnaires about psychological well-being will be administered prior to and after the participation to the program and at a 1-month follow-up. After the program, a usability questionnaire and a semi-structured interview will be conducted to assess the usability of the mindfulness program and gather participants' feedback. For each group, differences prior to and after the mindfulness program will be assessed using a repeated measure analysis of variance. The transcribed verbatim of the semi-structured interview will be analyzed independently using thematic content analysis by 2 members of the research team. Phase 3) Based on the results from Phase 2, modifications will be made to the online mindfulness program. If warranted, the testing phase will be replicated with a second cohort of participants. This project will lead to the development of an online mindfulness program suitable for stroke survivors and their caregivers to improve quality of life and psychological well-being. This project will help guide the development of a planned intervention study.
Interventions
BEHAVIORALMindfulness 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.
Sponsors
University of Southern California
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stroke (for stroke survivors) or caregiver of someone who have had a stroke * Ability to access Internet using a computer, a tablet and/or a smart phone * Ability to provide informed consent * Fluent in English
Exclusion criteria
* Severe language impairments * Regular meditation or participation in a mindfulness program in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stroke Impact Scale | from baseline to 3 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in National Institute of Health Perceived Stress Survey | from baseline to 3 weeks | 10-item self-reported measure assessing perceived stress. Scores range from 10 to 50, with higher scores indicating greater levels of perceived stress. |
| Change in Single-Item Sleep Quality Scale | from baseline to 3 weeks | 1-item sleep quality scale ranging from 1 to 10. Higher scores indicate better sleep quality. |
| Change in Hospital Anxiety and Depression Scale | from baseline to 3 weeks | 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). |
| Adapted Post-Study System Usability Questionnaire | 3 weeks | 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. |
| Change in Zarit Burden Interview | from baseline to 3 weeks | 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. |
| Change in World Health Organization Quality of Life-bref | from baseline to 3 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stroke Survivors Participants who have had a stroke | 13 |
| Caregivers Participants who care for someone who have had a stroke | 3 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregiver only took part in the qualitative interview (no quantitative outcomes) | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Stroke Survivors | Total | Caregivers |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 12.1 | 64.1 years STANDARD_DEVIATION 13.6 | 59.7 years STANDARD_DEVIATION 21.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 15 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 1 Participants |
| Region of Enrollment United States | 13 Participants | 16 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 3 |
| other Total, other adverse events | 0 / 13 | 1 / 3 |
| serious Total, serious adverse events | 0 / 13 | 0 / 3 |
Outcome results
Primary
Change in Stroke Impact Scale
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Change in Stroke Impact Scale | 2.3 score on a scale | Standard Deviation 24.3 |
Secondary
Adapted Post-Study System Usability Questionnaire
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Adapted Post-Study System Usability Questionnaire | 14.3 score on a scale | Standard Deviation 7.9 |
| Caregivers | Adapted Post-Study System Usability Questionnaire | 24.5 score on a scale | Standard Deviation 12 |
Secondary
Change in Hospital Anxiety and Depression Scale
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).
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Change in Hospital Anxiety and Depression Scale | 0.9 score on a scale | Standard Deviation 3.5 |
| Caregivers | Change in Hospital Anxiety and Depression Scale | 5 score on a scale | Standard Deviation 1.4 |
Secondary
Change in National Institute of Health Perceived Stress Survey
10-item self-reported measure assessing perceived stress. Scores range from 10 to 50, with higher scores indicating greater levels of perceived stress.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Change in National Institute of Health Perceived Stress Survey | 1.1 score on a scale | Standard Deviation 5.1 |
| Caregivers | Change in National Institute of Health Perceived Stress Survey | 4.5 score on a scale | Standard Deviation 3.5 |
Secondary
Change in Single-Item Sleep Quality Scale
1-item sleep quality scale ranging from 1 to 10. Higher scores indicate better sleep quality.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Change in Single-Item Sleep Quality Scale | 0.9 units on a scale | Standard Deviation 2.1 |
| Caregivers | Change in Single-Item Sleep Quality Scale | 4 units on a scale | Standard Deviation 1.4 |
Secondary
Change in World Health Organization Quality of Life-bref
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.
Time frame: from baseline to 3 weeks
Population: One caregiver group did not receive the intervention (only did the qualitative portion of the study).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Change in World Health Organization Quality of Life-bref | 6.25 score on a scale | Standard Deviation 4.7 |
Secondary
Change in Zarit Burden Interview
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.
Time frame: from baseline to 3 weeks
Population: One caregiver group did not receive the intervention (only did the qualitative portion of the study).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Survivors | Change in Zarit Burden Interview | 3 score on a scale | Standard Deviation 9.9 |