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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Other: Web-Based Support and Education Program 1
* Other: Web-Based Support and Education Program 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based Support and Education Program 1<br>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<br>* 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.<br>|
| Experimental: Web-Based Education and Support Program 2<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Caregivers, Spouse, Partner, Caregiver Burden, Spinal Cord Injury, Internet Based Intervention, Grief, Emotions, Clinical Trial