Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827095
• Other study ID #: L-1097-20
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 29, 2023

Study information

• Verified date: November 2021
• Source: Kessler Foundation
• Contact: Jeanne Zanca, PhD, MPT
• Phone: 973-324-3558
• Email: jzanca[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 29, 2023
• Est. primary completion date: January 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Web-Based Support and Education Program 1
The classes will discuss topics related to caregiving for someone with a spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about one hour per week that relate to the topics discussed in class.
• Web-Based Support and Education Program 2
The classes will discuss topics related to caregiving for someone with a spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about one hour per week that relate to the topics discussed in class.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score	Change in behavior and emotion, measured by the Behavioral Inhibition/ Behavioral Activation Scale. The extent to which behavior and emotions change over time will be measured with the Behavioral Inhibition/ Behavioral Activation Scale. The BIS/BAS scale is composed of three subscales; (1) drive, which measures the persistent pursuit of goals, (2) fun seeking, which measures the desire for new rewards and the willingness to approach a potentially rewarding event, and (3) reward responsiveness, which measures positive responses to rewarding outcomes.	Average scores obtained during baseline (pre-program) compared to scores obtained immediately after program completion.
Secondary	Change in Marit-Meuser Caregiver Grief Inventory (CGI) scores	50-item inventory scored on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree," used to assess grief before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Change in Satisfaction with Life Scale scores	5-item measure of the concept of global life satisfaction before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Change in Zarit Burden Interview (ZBI) scores	22-item questionnaire that assesses caregivers' perceptions of burden before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Changs in Duke Social Support Index (DSSI) scores	11-item short form that assesses perceived support and non-support from various people in life before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Change in Patient Health Questionnaire scores	A self-report questionnaire with subscales for depression and anxiety-related symptoms before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Change in NIH Toolbox Loneliness Survey (Fixed Form) scores	Self-report measure of perceptions of loneliness using a 5-item fixed length form before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Change in Connor-Davidson Resilience Scale scores	10-item self-report instrument that assesses resilience before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Change in Couples Satisfaction Index scores	8-item self-report questionnaire assessing perceived strength, comfort, reward, happiness, warmth of relationship to one's partner before and after participation in the program.	End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline
Secondary	Long-Term Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score	Change in behavior and emotion, measured by the Behavioral Inhibition/ Behavioral Activation Scale. The extent to which behavior and emotions change over time will be measured with the Behavioral Inhibition/ Behavioral Activation Scale. The BIS/BAS scale is composed of three subscales; (1) drive, which measures the persistent pursuit of goals, (2) fun seeking, which measures the desire for new rewards and the willingness to approach a potentially rewarding event, and (3) reward responsiveness, which measures positive responses to rewarding outcomes.	3-months post intervention versus baseline, 6-months post intervention versus baseline