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

NCT06364813 | Not Yet Recruiting

• 1 other identifier: H20-01461
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries; Caregiver Burden

Keywords

Caregiving; eHealth; online education; family caregivers

Outcome Measures

Primary Outcomes (1)

• Family caregivers' subjective burden as assessed by the Zarit Burden Interview

  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 Outcomes (8)

• Participants' objective burden as assessed by the Dutch Objective Burden Inventory

  0 months, 3 months, and 6 months

• Participants' distress as assessed by the Depression, Anxiety and Stress Scale

  0 months, 3 months, and 6 months

• Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale

  0 months, 3 months, and 6 months

• Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey

  0 months, 3 months, and 6 months

• Caregiver competence as assessed by the Caregiving Competence Scale

  0 months, 3 months, and 6 months

Other Outcomes (4)

• 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

  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

  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

  Through study completion, an average of 6 months

Study Arms (2)

COMPANION Group

EXPERIMENTAL

eHealth education: participants receive family caregiving education through the COMPANION eHealth program.

Other: COMPANION eHealth Program

No Intervention

NO INTERVENTION

Control group participants will receive the usual care available at their local rehabilitation clinic.

Interventions

COMPANION eHealth Program OTHER

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.

COMPANION Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• The Craig H. Neilsen Foundation: collaborator

Related Publications (1)

• Mohammadi S, Erlander B, Cathcart H, Robillard JM, Sauvageau S, Whitehurst DGT, Pauly E, Page B, Miller WC. Codeveloping a Novel Intervention to Promote the Well-Being of Family Caregivers of Individuals With Spinal Cord Injury: Protocol for a Feasibility Randomized Control Trial. JMIR Res Protoc. 2025 Sep 25;14:e67709. doi: 10.2196/67709.

  PMID: 40998319 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Caregiver Burden

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• William C Miller, PhD

  University of British Columbia

  STUDY CHAIR

Central Study Contacts

Somayyeh Mohammadi, PhD

CONTACT

604 734 1313; somayyeh.mohammadi@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: April 15, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share