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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827095
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Diseases Other: Web-Based Support and Education Program 1 Other: Web-Based Support and Education Program 2 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : January 29, 2023
Estimated Study Completion Date : April 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score [ Time Frame: Average scores obtained during baseline (pre-program) compared to scores obtained immediately after program completion. ]
    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.


Secondary Outcome Measures :
  1. Change in Marit-Meuser Caregiver Grief Inventory (CGI) scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    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.

  2. Change in Satisfaction with Life Scale scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    5-item measure of the concept of global life satisfaction before and after participation in the program.

  3. Change in Zarit Burden Interview (ZBI) scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    22-item questionnaire that assesses caregivers' perceptions of burden before and after participation in the program.

  4. Changs in Duke Social Support Index (DSSI) scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    11-item short form that assesses perceived support and non-support from various people in life before and after participation in the program.

  5. Change in Patient Health Questionnaire scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    A self-report questionnaire with subscales for depression and anxiety-related symptoms before and after participation in the program.

  6. Change in NIH Toolbox Loneliness Survey (Fixed Form) scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    Self-report measure of perceptions of loneliness using a 5-item fixed length form before and after participation in the program.

  7. Change in Connor-Davidson Resilience Scale scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    10-item self-report instrument that assesses resilience before and after participation in the program.

  8. Change in Couples Satisfaction Index scores [ Time Frame: End of program versus baseline; 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    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.

  9. Long-Term Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score [ Time Frame: 3-months post intervention versus baseline, 6-months post intervention versus baseline ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827095


Contacts
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Contact: Jeanne Zanca, PhD, MPT 973-324-3558 jzanca@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07050
Contact: Jeanne Zanca, PhD, MPT    973-324-3558    jzanca@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Jeanne Zanca, PhD, MPT Kessler Foundation
More Information
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04827095    
Other Study ID Numbers: L-1097-20
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kessler Foundation:
Caregivers
Spouse
Partner
Caregiver Burden
Spinal Cord Injury
 Quality of Life
Internet Based Intervention
Grief
Emotions
Clinical Trial
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System