Clinical trial NCT06364813: Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury
Official title: Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Caregiver Burden
Keywords: Caregiving
eHealth
online education
family caregivers
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2024-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Family caregivers' subjective burden as assessed by the Zarit Burden Interview
timeFrame: 0 months, 3 months, and 6 months
Secondary outcomes:
measure: Participants' objective burden as assessed by the Dutch Objective Burden Inventory
timeFrame: 0 months, 3 months, and 6 months
measure: Participants' distress as assessed by the Depression, Anxiety and Stress Scale
timeFrame: 0 months, 3 months, and 6 months
measure: Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale
timeFrame: 0 months, 3 months, and 6 months
measure: Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey
timeFrame: 0 months, 3 months, and 6 months
measure: Caregiver competence as assessed by the Caregiving Competence Scale
timeFrame: 0 months, 3 months, and 6 months
measure: Caregiver costs as assessed by the Caregiver Indirect and Informal Care Cost Assessment Questionnaire
timeFrame: 0 months, 3 months and 6 months
measure: Participants' opinion regarding the usability of the implementation as assessed by the System Usability Scale
timeFrame: 3 months and 6 months
measure: Participants' experience using the implementation as assessed by a qualitative interview
timeFrame: 6 months
Other outcomes:
measure: 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
timeFrame: Through study completion, an average of 6 months
measure: 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
timeFrame: Through study completion, an average of 6 months
measure: A composite measure of internet stability, participant processing time, and treatment administration issues will be evaluated as "successful" or "revise" according to expectations
timeFrame: Through study completion, an average of 6 months
measure: A measure of dose level of training time
timeFrame: Through study completion, an average of 6 months
Locations:
Study officials:
affiliation: University of British Columbia
name: William C Miller, PhD
role: STUDY_CHAIR
References: