Last reviewed · How we verify
Caregiver Self-Management of Stress
NA trial testing Caregiver SOS in Caregiver Distress in 199 participants. Completed in 31 March 2024.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 199 |
| Start date | 28 December 2020 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 March 2024 |
| Sites | 2 locations across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Caregiver Distress or Job Stress. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Global measure of psychological distress; scores range from 10-50, with higher scores indicating worse outcomes (higher levels of distress)
| Group | Value | 95% CI |
|---|---|---|
| Caregiver SOS | 23.38 | ± 7.56 |
| Usual Care | 23.79 | ± 8.03 |
25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%
| Group | Value | 95% CI |
|---|---|---|
| Caregiver SOS | 62.15 | ± 21.18 |
| Usual Care | 59.71 | ± 19.79 |
25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%
| Group | Value | 95% CI |
|---|---|---|
| Caregiver SOS | 30.38 | ± 31.65 |
| Usual Care | 30.84 | ± 29.09 |
25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%
| Group | Value | 95% CI |
|---|---|---|
| Caregiver SOS | 63.06 | ± 23.9 |
| Usual Care | 62.41 | ± 23.79 |
25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%
| Group | Value | 95% CI |
|---|---|---|
| Caregiver SOS | 67.12 | ± 25.06 |
| Usual Care | 65.34 | ± 22.66 |
Unpaid informal caregivers (CGs), such as family and friends, who are also employed may be at significant risk of experiencing burden and stress. This may be especially true for CGs who provide care to care recipients coping with behavioral health issues associated with conditions like depression, anxiety, post-traumatic stress disorder and traumatic brain injury. Stress not only increases the CG's risk of workplace difficulties, illness, and poor quality of life, but also impacts the CG's ability to provide care for the care recipient. The primary aim of this randomized study is to examine the impact of a novel intervention, Caregiver SOS (Self-Management of Stress), on CG distress and work performance and productivity. Caregiver SOS is delivered by phone and offers evidence-based, work and CG role performance-focused self-management counseling to employed CGs. Study findings will ultimately shed light on whether a program that specifically addresses caregiving-work balance is effective in improving CGs' wellbeing and work functioning and the quality of Veterans' care.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04337021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing