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

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Diseases; Spinal Cord Injuries
• Intervention / Treatment: Other: Web-Based Support and Education Program 1; Other: Web-Based Support and Education Program 2

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeanne Zanca, PhD, MPT; Phone Number: 973-324-3558; Email: jzanca@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07050
      • Recruiting
      • Kessler Foundation
      • Contact: Jeanne Zanca, PhD, MPT; Phone Number: 973-324-3558; Email: jzanca@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Web-Based Support and Education Program 1; The support and education program involves 6 weeks of web-based classes (75-90 minutes per class) given once per week with weekly homework assignments of approximately one hour per week.	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.
EXPERIMENTAL: Web-Based Education and Support Program 2; The support and education program involves 6 weeks of web-based classes (75-90 minutes per class) given once per week with weekly homework assignments of approximately one hour per week.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Jeanne Zanca, PhD, MPT, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): January 29, 2023
• Study Completion (ANTICIPATED): April 29, 2023

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Caregiver Burden; Emotions; Spinal Cord Injury; Clinical Trial; Caregivers; Partner; Spouse; Grief; Internet Based Intervention
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: L-1097-20

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