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

NCT04827095 | Unknown

• 1 other identifier: L-1097-20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Marit-Meuser Caregiver Grief Inventory (CGI) scores

  End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline

• Change in Satisfaction with Life Scale scores

  End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline

• Change in Zarit Burden Interview (ZBI) scores

  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

  End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline

• Change in Patient Health Questionnaire scores

  End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline

Study Arms (2)

Web-Based Support and Education Program 1

EXPERIMENTAL

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

Web-Based Education and Support Program 2

EXPERIMENTAL

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

Interventions

Web-Based Support and Education Program 1 OTHER

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 1

Web-Based Support and Education Program 2 OTHER

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 Education and Support Program 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07050, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Caregiver Burden

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeanne Zanca, PhD, MPT

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanne Zanca, PhD, MPT

CONTACT

973-324-3558; jzanca@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 1, 2021
• Primary Completion: January 29, 2023
• Study Completion: April 29, 2023
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)