Clinical trial NCT04827095: Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury
Official title: Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: Caregivers
Spouse
Partner
Caregiver Burden
Spinal Cord Injury
Quality of Life
Internet Based Intervention
Grief
Emotions
Clinical Trial
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

Detailed description: SCI particularly affects partners (spouses or other types of significant others), as they face changes in relationship dynamics and identity as they take on a caregiver role. The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Fluent in English (reading and writing)
* Romanic partner of a person with SCI (regardless of martial status) for at least one year prior to injury
* Live in a private residence with their partner with SCI
* Partner is at least 3 months post discharge from inpatient rehabilitation
* At least 6 months since their partner's injury
* Provide care to their partner with SCI on a daily basis
* Have access to the internet in a private location

Exclusion Criteria:

* Participant reports a diagnosis of a schizoaffective disorder, bipolar personality disorder, or severe depression
* History of hospitalization for depression treatment

Primary outcomes:
measure: Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score
timeFrame: Average scores obtained during baseline (pre-program) compared to scores obtained immediately after program completion.
Secondary outcomes:
measure: Change in Marit-Meuser Caregiver Grief Inventory (CGI) scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Change in Satisfaction with Life Scale scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Change in Zarit Burden Interview (ZBI) scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Changs in Duke Social Support Index (DSSI) scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Change in Patient Health Questionnaire scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Change in NIH Toolbox Loneliness Survey (Fixed Form) scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Change in Connor-Davidson Resilience Scale scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Change in Couples Satisfaction Index scores
timeFrame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
measure: Long-Term Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score
timeFrame: 3-months post intervention versus baseline, 6-months post intervention versus baseline
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Jeanne Zanca, PhD, MPT
role: PRINCIPAL_INVESTIGATOR
References: