Spinal Cord InjuriesNCT04827095
Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury
A study testing Web-Based Support and Education Program 1 and Web-Based Support and Education Program 2 in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Kessler Foundation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- Web-Based Support and Education Program 1 and Web-Based Support and Education Program 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participant reports a diagnosis of a schizoaffective disorder, bipolar personality disorder, or severe depression
- History of hospitalization for depression treatment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07050
Jeanne Zanca, PhD, MPT, 973-324-3558, jzanca@kesslerfoundation.org
About this study
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).
Read the 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).
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- Web-Based Support and Education Program 1, Web-Based Support and Education Program 2
- Keywords
- Caregivers, Spouse, Partner, Caregiver Burden, Spinal Cord Injury, Quality of Life, Internet Based Intervention, Grief, Emotions, Clinical Trial
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Support and Education Program 1Other
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 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Web-Based Support and Education Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-months post intervention versus baseline, 6-months post intervention versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Mar 2021
- Primary completion29 Jan 2023 (estimated)
- Study completion29 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne Zanca, PhD, MPT, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827095
- Sponsor's protocol ID
- L-1097-20
- Status last verified
- Nov 2021
- First submitted
- 30 Mar 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04827095
- Acronym / sponsor ID
- L-1097-20
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Keywords
- Caregivers, Spouse, Partner, Caregiver Burden, Spinal Cord Injury, Quality of Life, Internet Based Intervention, Grief
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 29 Jan 2023 (estimated)
- Study completion
- 29 Apr 2023 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based Support and Education Program 1 | Experimental | Other: Web-Based Support and Education Program 1The 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. |
| Web-Based Education and Support Program 2 | Experimental | Other: Web-Based Support and Education Program 2The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Participant reports a diagnosis of a schizoaffective disorder, bipolar personality disorder, or severe depression
- History of hospitalization for depression treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Support and Education Program 1The 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. | Other | Web-Based Support and Education Program 1 |
| Web-Based Support and Education Program 2The 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. | Other | Web-Based Education and Support Program 2 |
Primary outcome
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Zanca, PhD, MPT principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Support and Education Program 1 and Web-Based Support and Education Program 2 in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne Zanca, PhD, MPT (973-324-3558, jzanca@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2021.