Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury

May 13, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 no earlier than 6 months prior to participation

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COMPANION Group
eHealth education: participants receive family caregiving education through the COMPANION eHealth program.
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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' 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
Caregiver costs as assessed by the Caregiver Indirect and Informal Care Cost Assessment Questionnaire
Time Frame: 0 months, 3 months and 6 months
The Caregiver Indirect and Informal Care Cost Assessment Questionnaire (CIIQ) consists of 13 items with information including, but not limited to, work status, time missed at work, productivity, and physical and emotional caregiving duties. Responses are open-ended apart from one item using a 10-point scale ranging from 0 ("could work as usual") to 10 ("Could not work at all"). Calculations will be conducted to estimate indirect and informal caregiver costs. Total scores report cost in dollars and can range from as low as zero to any maximum number. Higher scores indicate greater financial impact due to informal care costs. The CIIQ will be coupled with a bespoke item asking about additional money fcSCI spend on themselves. To minimize concerns about recall, a one-week recall period will be used for the CIIQ and a three-month recall period will be used for the bespoke item.
0 months, 3 months and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Craig H. Neilsen Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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