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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Web-Based Support and Education Program 1

Web-Based Support and Education Program 2

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring Caregivers, Spouse, Partner, Caregiver Burden, Spinal Cord Injury, Quality of Life, Internet Based Intervention, Grief, Emotions, Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Web-Based Support and Education Program 1

Web-Based Education and Support Program 2

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Change in Satisfaction with Life Scale scores

5-item measure of the concept of global life satisfaction before and after participation in the program.

Change in Zarit Burden Interview (ZBI) scores

22-item questionnaire that assesses caregivers' perceptions of burden before and after participation in the program.

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.

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.

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.

Change in Connor-Davidson Resilience Scale scores

10-item self-report instrument that assesses resilience before and after participation in the program.

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.

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.

Full Information

NCT ID

NCT04827095

First Posted

March 30, 2021

Last Updated

November 11, 2021

Sponsor

Kessler Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04827095

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

January 29, 2023 (Anticipated)

Study Completion Date

April 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Web-Based Support and Education Program 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Web-Based Education and Support Program 2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Web-Based Support and Education Program 1

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Web-Based Support and Education Program 2

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Behavioral Inhibition/ Behavioral Activation Scale (BIS/BAS) score

Description

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.

Time Frame

Average scores obtained during baseline (pre-program) compared to scores obtained immediately after program completion.

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame