- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06364813
Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury
April 19, 2024 updated by: Somayyeh Mohammadi, University of British Columbia
Family caregivers of individuals with spinal cord injury (SCI) provide the majority of care and are at high risk of experiencing caregiver burden, which not only impacts caregivers' own wellbeing, but also their ability to respond to patients' needs.
Health education using online approaches (eHealth) has the potential to improve quality of care, enhance communication between health care users and providers, reduce costs and increase access to existing knowledge and education for family caregivers.
Here, the investigators propose a research study to assess the quality of the eHealth program.
The findings of this study will lead to the refinement of the eHealth program.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
People with spinal cord injury (SCI) experience an irreversible neurological impairment.
Each year there are more than 17,000 and 3,500 new cases of SCI in the United States and Canada, respectively.
The estimated lifetime health care and direct economic cost that SCI imposes is between $1.6m and $3m (CAD) per person.
However, this number is substantially higher when unpaid care provided by family caregivers is considered.
Family caregivers of individuals with SCI provide the majority of care, from assistance with activities of daily living to managing finances.
Family caregivers report negative social and health-related consequences such as difficulties in maintaining a social life or full-time employment.
Family caregivers also tend to ignore their own mental and physical health needs.
The burden and distress caused by caregiving responsibilities not only impacts caregivers, but also caregivers' ability to respond to the patients' needs.
Therefore, it is essential to better understand and address the needs and challenges faced by family caregivers.
In preliminary work conducted to explore these issues, the investigators examined the needs and challenges of family caregivers of individuals with SCI through conducting a systematic review, an online survey and semi-structured interviews.
Working with end-users partners and building on this line of research, the investigators aim to provide the information and resources required and requested by family caregivers to address their needs via an eHealth tool.
Through this needs-based technology intervention, the investigators' goal is to improve the physical and psychological wellbeing of family caregivers of individuals with SCI and, ultimately, to improve the well-being of the individuals with SCI.
In addition, the investigators will investigate patterns of health care use among family caregivers and individuals with SCI as a means to evaluate the impact of the intervention.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Somayyeh Mohammadi, PhD
- Phone Number: 6262 604 734 1313
- Email: somayyeh.mohammadi@ubc.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Family caregiver of an adult individual with SCI
- Must be older than 18 years old
- Must live in Canada
- Must live with the individual with SCI in the community
- The spinal cord injury of the individual with SCI must have happened within the last 6 months to 5 years before conducting the study
Exclusion Criteria:
- Family caregiver with major medical and physical conditions that needs routine visits to medical doctors (e.g., cancer)
- Family caregivers of individuals with SCI who are still in a rehabilitation facility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COMPANION Group
eHealth education: participants receive family caregiving education through the COMPANION eHealth program.
|
COMPANION consists of online, self-paced educational modules with information on a range of topics such as providing medical care, applying for financial aid and home aid, working on the relationship with the care recipient, dealing with mental health issues, and learning life skills.
|
No Intervention: No Intervention
Control group participants will receive the usual care available at their local rehabilitation clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family caregivers' subjective burden as assessed by the Zarit Burden Interview
Time Frame: 0 months, 3 months, and 6 months
|
The 12-item Zarit Burden Interview uses a 5-point scale to measure family caregivers' subjective burden by asking participants how often they experience certain feelings.
Individual responses range from 0 (never) to 4 (nearly always) and are added to generate a total score.
Total scores can range from a minimum of 0 to a maximum of 48.
A total score ranging between 0-10 indicates no to mild burden, 10-20 indicates mild to moderate burden, and >20 indicates high burden.
The Zarit Burden Interview will be administered via survey at 3 timepoints.
|
0 months, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants' objective burden as assessed by the Dutch Objective Burden Inventory
Time Frame: 0 months, 3 months, and 6 months
|
The 38-item Dutch Objective Burden Inventory will be used to measure family caregivers' objective burden by assessing participants' perceived burden relating to care activities over the past three months.
Individual responses are scored (1 = Not at all burdensome, 2 = somewhat burdensome, 3 = very burdensome) and the average calculated to produce a total score (ranging from 1 to 3).
Higher averages indicate higher objective burden.
The Dutch Objective Burden Inventory will be administered via survey at 3 timepoints.
|
0 months, 3 months, and 6 months
|
Participants' distress as assessed by the Depression, Anxiety and Stress Scale
Time Frame: 0 months, 3 months, and 6 months
|
The Depression, Anxiety and Stress Scale (DASS) contains 21 items assessing distress over the past week using a 4-point Likert scale (0=never, 3=always).
Responses for each item will be scored and averaged into a single distress indicator with higher scores indicating more distress.
The DASS will be administered via survey at 3 timepoints.
|
0 months, 3 months, and 6 months
|
Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale
Time Frame: 0 months, 3 months, and 6 months
|
The Dyadic Adjustment Scale (DAS-32) consists of 32 items for measuring the level of relationship quality satisfaction among dyads in general and during the past few weeks.
Total scores range from 0 to 151.
Higher scores indicate less distress and high adjustment.
The DAS-32 will be administered via survey at 3 timepoints.
|
0 months, 3 months, and 6 months
|
Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey
Time Frame: 0 months, 3 months, and 6 months
|
The Veterans RAND 12-item Health Survey (VR-12) is a questionnaire that will be used to measure family caregivers' health-related quality of life during the past four weeks and compared to their health one year ago.
Items relate to general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. 2 separate scores are generated from responses, a "Physical Health Summary Measure (PCS-physical component score)" and a "Mental Health Summary Measure (MCS-mental component score)".
The VR-12 scoring algorithm is used to score PCS and MCS based on weights derived from 877,775 responses to a Veterans RAND 36-Item Health Survey (VR-36) that was administered federally to American veterans in 1999, resulting in variable minimum and maximum score values.
Higher PCS and MCS scores indicate better health.
The VR-12 will be administered via survey at 3 timepoints.
|
0 months, 3 months, and 6 months
|
Caregiver competence as assessed by the Caregiving Competence Scale
Time Frame: 0 months, 3 months, and 6 months
|
Caregiver competence is measured by a 4-item Likert scale asking participants to rate feelings about their competency and performance of their caregiving role.
Response options range from 4 = "very much" to1 = "not at all".
Total score values range from 0 to 12 with higher scores indicating higher caregiving competence.
The Caregiving Competence Scale will be administered via survey at 3 timepoints.
|
0 months, 3 months, and 6 months
|
Participants' opinion regarding the usability of the implementation as assessed by the System Usability Scale
Time Frame: 3 months and 6 months
|
The System Usability Scale (SUS) consists of a 10-item questionnaire with five response options scored on a Likert scale ranging from "Strongly agree" to "Strongly disagree."
It is used to measure usability of the eHealth implementation based on participants' experience using COMPANION over the last 3 months.
It will be administered only to participants in the intervention group via survey at 2 timepoints.
Raw scores range from 0-40 and are algorithmically converted into meaningful SUS scores ranging from 0-100.
Higher scores indicate higher perceived usability.
|
3 months and 6 months
|
Participants' health care use as assessed by a bespoke questionnaire
Time Frame: 3 months and 6 months
|
A bespoke questionnaire will be created to capture information about health care use and other care-related out-of-pocket expenses.
This measure is currently in the process of being developed.
|
3 months and 6 months
|
Participants' experience using the implementation as assessed by a qualitative interview
Time Frame: 6 months
|
Optional semi-structured interviews (45-60 minutes) will be used to explore fcSCI's experience with the eHealth implementation.
Interview guides will be created to ask participants to share their perspective on advantages and disadvantages of the program.
Participating in the interview will only be offered to participants in the intervention group.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A composite measure of recruitment rate, consent rate, retention rate, perceived benefit, and assessor masking will be evaluated as "successful" or "revise" according to expectations
Time Frame: Through study completion, an average of 6 months
|
Recruitment rate will be successful if a total of 40 participants and a mean of 3-4 participants per month are recruited.
Consent rate will be successful if <10% of participants refuse to consent.
Retention rate will be considered successful if >80% of participants complete data collection at 6 months.
Perceived benefit will be assessed by responses to the System Usability Scale (at 3 months and 6 months) and the qualitative interview at 6 months, and will be successful if >85% of responses to the SUS are "strongly agree/agree", and if analysis of interview responses will inform clinical importance.
Assessor masking will be considered successful if 100% of participants do not unmask their treatment to the study assessor.
The evaluation of these feasibility indicators will be used to assess process issues in the study protocol.
|
Through study completion, an average of 6 months
|
A composite measure of treatment adherence, participant and evaluator burden during data collection, and expert burden will be evaluated as "successful" or "revise" according to expectations
Time Frame: Through study completion, an average of 6 months
|
Treatment adherence will be considered successful if >85% of participants complete all the modules in COMPANION.
Participant and evaluator burden will be considered successful if (i) >85% of participants complete baseline data collection (at 0 months) in ≤2 hours, and (ii) >85% of participants complete data collection at 3 months and 6 months in ≤1.5 hours.
Expert burden will be considered successful if (i) the mean time spent per participant is <2 hours during the first 3 months of the study, (ii) the mean time spent per participant is <1 hour during the following 3 months of the study, and (iii) research staff make follow-up phone calls for clarification with <20% of participants.
The evaluation of these feasibility indicators will be used to assess resource issues in the study protocol.
|
Through study completion, an average of 6 months
|
A composite measure of internet stability, participant processing time, and treatment administration issues will be evaluated as "successful" or "revise" according to expectations
Time Frame: Through study completion, an average of 6 months
|
Internet stability will be assessed by reported downtime from accessing COMPANION due to technical or mechanical issues and will be considered successful if more than 90% of participants are not without internet for more than 2 days.
Participant processing time will be assessed by time passing from data collection to treatment and will be considered successful if the mean time between data collection and accessing treatment is less than 10 days at initial data collection (0 months) and data collection at 3 months.
Treatment administration issues will be assessed by study educator responses to a post-treatment evaluation form and will be considered successful if any issues identified through the evaluation form are deemed modifiable without requiring substantial changes to the study protocol.
The evaluation of these feasibility indicators will be used to assess management issues in the study protocol.
|
Through study completion, an average of 6 months
|
A measure of dose level of training time
Time Frame: Through study completion, an average of 6 months
|
Dose level (e.g., time spent in the education modules) response will be assessed by the correlation between time spent (in minutes) using the module and change in burden scores.
It will be considered successful if there is a positive correlation.
The evaluation of these feasibility indicators will be used to assess treatment issues in the study protocol.
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: William C Miller, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
February 15, 2024
First Submitted That Met QC Criteria
April 9, 2024
First Posted (Actual)
April 15, 2024
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H20-01461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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