Caregiver Stress SyndromeNCT04535284
Coaching Intervention for Caregivers of Persons With Stroke
A study testing Coaching in people with Caregiver Stress Syndrome and Caregiver Burnout, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Caregiver Stress Syndrome, Caregiver Burnout, Stroke, Acute
- What is being tested?
- Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivor criteria: First-time stroke, discharged from hospital within the past 30 days.
- Caregiver criteria: Informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. Passes cognition screen, willing to use teleconference using phone, tablet, or computer.
- Both: 18 to 80 years of age, understand and speak English
Who cannot join
- Children
- 81 years of age or older
- Unable to understand and speak English
- Does not provide consent
- Caregiver does not pass cognition screen
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Namrata Grampurohit, PhD, 206-353-6054, namrata.grampurohit@jefferson.edu
About this study
Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.
Read the detailed description
Caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. Caregivers are routinely engaged during hospital discharge for education and training. However, the critical period after discharge is largely unsupported. The proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the "Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health and reduction in readmissions for stroke survivor. The study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. A pilot randomized controlled trial will be conducted with two parallel groups, "Health Coaching-in-Context" and usual care. A sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from University hospitals and randomly assigned after consenting. The occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. Data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.
- Conditions
- Caregiver Stress Syndrome, Caregiver Burnout, Stroke, Acute
- Being tested
- Coaching
- Keywords
- Caregiver, Stroke, Coaching, Stress, Self-efficacy, Re-admission, Burden
- Medical subject headings
- Caregiver Burden, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
Also called Health Coaching in Context
"Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health through occupational therapy coaching.
| Study group | Role | What they receive |
|---|---|---|
| Coaching | Experimental | Health Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference. Receives: Behavioral: Coaching |
| Usual Care | No intervention | The usual care group does not get any intervention but continues with any of their usual activities that would otherwise would have been provided to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.
Measured: Week 1
Canadian Occupational Performance Measure
Measure of performance and satisfaction with performance of daily tasks.Each domain score is out of 10, minimum is 1, and higher scores are better.
Measured: Week 12
Canadian Occupational Performance Measure
Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.
Measured: Week 15
Secondary outcomes (18)
Re-admission
Number of subjects readmitted. Lower is better.
Measured: 30 day re-admission
Re-admission
Number of subjects readmitted. Lower is better.
Measured: 60 day re-admission
Re-admission
Number of subjects readmitted. Lower is better.
Measured: 90 day re-admission
Revised Caregiver Self-efficacy scale
Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Measured: Week 1
Revised Caregiver Self-efficacy scale
Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Measured: Week 12
Revised Caregiver Self-efficacy scale
Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy
Measured: Week 15
Zarit Burden Interview
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Measured: Week 1
Zarit Burden Interview
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Measured: Week 12
Zarit Burden Interview
Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.
Measured: Week 15
WHO-BREF Quality of Life scale
World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each
Measured: Week 1
WHO-BREF Quality of Life scale
World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each
Measured: Week 12
WHO-BREF Quality of Life scale
World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each
Measured: Week 15
Single-item life satisfaction scale
Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question
Measured: Week 1
Single-item life satisfaction scale
Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question
Measured: Week 12
Single-item life satisfaction scale
Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question
Measured: Week 15
Stroke Impact Scale
The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
Measured: Week 1
Stroke Impact Scale
The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
Measured: Week 12
Stroke Impact Scale
The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.
Measured: Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start24 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Stress SyndromeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled trial design with two parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535284
- Sponsor's protocol ID
- 20D.718
- Status last verified
- Oct 2021
- First submitted
- 6 Aug 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared within the research team. De-identified data will be made publicly available on a repository.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching Intervention for Caregivers of Persons With Stroke
- ClinicalTrials.gov ID
- NCT04535284
- Acronym / sponsor ID
- 20D.718
- Conditions
- Caregiver Stress Syndrome, Caregiver Burnout, Stroke, Acute
- Keywords
- Caregiver, Stroke, Coaching, Stress, Self-efficacy, Re-admission, Burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.
Detailed description
Caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. Caregivers are routinely engaged during hospital discharge for education and training. However, the critical period after discharge is largely unsupported. The proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the "Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health and reduction in readmissions for stroke survivor. The study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. A pilot randomized controlled trial will be conducted with two parallel groups, "Health Coaching-in-Context" and usual care. A sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from University hospitals and randomly assigned after consenting. The occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. Data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial design with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| Coaching | Experimental | Behavioral: CoachingHealth Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference. |
| Usual Care | No intervention | –The usual care group does not get any intervention but continues with any of their usual activities that would otherwise would have been provided to them. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Survivor criteria: First-time stroke, discharged from hospital within the past 30 days.
- Caregiver criteria: Informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. Passes cognition screen, willing to use teleconference using phone, tablet, or computer.
- Both: 18 to 80 years of age, understand and speak English
Key exclusion criteria (5 listed)
- Children
- 81 years of age or older
- Unable to understand and speak English
- Does not provide consent
- Caregiver does not pass cognition screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingAlso: Health Coaching in Context"Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health through occupational therapy coaching. | Behavioural | Coaching |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Week 1
Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.
Canadian Occupational Performance Measure
Time frame: Week 12
Measure of performance and satisfaction with performance of daily tasks.Each domain score is out of 10, minimum is 1, and higher scores are better.
Canadian Occupational Performance Measure
Time frame: Week 15
Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.
18 secondary outcomes
Re-admission
Time frame: 30 day re-admission
Re-admission
Time frame: 60 day re-admission
Re-admission
Time frame: 90 day re-admission
Revised Caregiver Self-efficacy scale
Time frame: Week 1
Revised Caregiver Self-efficacy scale
Time frame: Week 12
Revised Caregiver Self-efficacy scale
Time frame: Week 15
Zarit Burden Interview
Time frame: Week 1
Zarit Burden Interview
Time frame: Week 12
Zarit Burden Interview
Time frame: Week 15
WHO-BREF Quality of Life scale
Time frame: Week 1
WHO-BREF Quality of Life scale
Time frame: Week 12
WHO-BREF Quality of Life scale
Time frame: Week 15
Single-item life satisfaction scale
Time frame: Week 1
Single-item life satisfaction scale
Time frame: Week 12
Single-item life satisfaction scale
Time frame: Week 15
Stroke Impact Scale
Time frame: Week 1
Stroke Impact Scale
Time frame: Week 12
Stroke Impact Scale
Time frame: Week 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No. Data will be shared within the research team. De-identified data will be made publicly available on a repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching in people with Caregiver Stress Syndrome and Caregiver Burnout, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Namrata Grampurohit, PhD (2063536054, namrata.grampurohit@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Week 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.