Chronic Medical Conditions Clinical Trial
Official title:
A Web-based Program to Improve Chronic Illness Self-management by Engaging Patients and Informal Caregivers
The majority of Veterans will suffer from at least one chronic illness, often at great emotional and personal cost. Self-management is critical to improving physical and emotional outcomes, and many chronically ill Veterans receive self-management assistance from an informal caregiver, and both Veterans and informal caregivers experience individual and interpersonal stress as they navigate this journey. Yet, current clinical practices are not designed to effectively support the needs of both Veterans and their informal caregiver. Furthermore, self-management practices often require in-person visits, limiting access for Veterans and informal caregivers who live in rural areas, those with a physical disability, or those with financial challenges. This project tests a web-based, self-guided, behavioral intervention that targets the stress coping needs of Veterans with chronic illness and their informal caregivers. Results from this study could provide an important solution to the problem of poor self-management, which complicates the lives and prognosis of many Veterans.
Background: For the 80% of older Americans who have at least one chronic condition, sharing self-management responsibilities with caregivers (relatives or friends) predicts longevity, better health, better quality of life, and fewer hospitalizations. Caregivers often support patients in their self-management efforts. This can bring patients and caregivers closer but can also generate stress for both that can interfere with self-management. Yet, self-management programs rarely support the coping needs of patient-caregiver dyads. Significance: There are more than 5 million caregivers of Veterans; 75% of older Veterans receive some caregiver support. Caregivers incur individual financial and emotional costs even as they provide unpaid care. Having an effective self-management strategy that addresses the needs of both can improve outcomes and quality of life for millions of Veterans who suffer from chronic illnesses and their caregivers. This project addresses the priorities "Long-term care and Caregiving," "Virtual Care/Telehealth," and "Access to Care" and is consistent with the legislative goals of the MISSION Act. Innovation and Impact: This highly innovative proposal uses the novel concept that strengthening the interpersonal relationships between Veterans and caregivers can improve the self-management of chronic conditions. It challenges current clinical paradigms by addressing the collective stress coping needs of dyads. It is methodologically innovative because unlike many behavioral intervention trials, it assesses barriers and facilitators to plan for future implementation. The focus on technology-enabled tools is timely given how COVID19 has transformed care delivery. This project takes advantage of the unique capabilities of the VA health system to explore questions including robust caregiver support and virtual care programs. Specific Aims: With investments from VA HSR&D, the investigators have developed and successfully pilot tested a new theoretically-derived technology called Web-based Self-care Using Collaborative Coping EnhancEment in Diseases (web-SUCCEED). We propose to conduct a randomized clinical trial comparing web-SUCCEED to an enhanced usual care (EUC) control. The investigators will conduct a formative evaluation guided by the Consolidated Framework of Implementation Research (CFIR) to accelerate future implementation. 1. Assess whether web-SUCCEED improves Veteran outcomes of self-management compared to EUC, 4 weeks and 6 months following randomization. 2a. Assess whether web-SUCCEED improves patient stress and quality of life. 2b. Assess whether web-SUCCEED improves caregiver stress, quality of life and caregiver burden. 2c. Examine communication, dyadic coping, mutuality, and relationship quality as mediators of primary and secondary outcomes (Aims 1, 2a, 2b). 3. Guided by CFIR, conduct a formative evaluation involving key stakeholder interviews to understand barriers and facilitators of future implementation. Methodology: The investigators will recruit 280 cognitively intact Veterans from VA Palo Alto Health Care System who are managing at least one common chronic condition, and their caregivers. Veteran-caregiver dyads will be randomized 1:1 to web-SUCCEED or EUC. Veteran and caregiver assessments will take place at baseline, then again at 4 weeks and 6 months. The formative evaluation will be guided by CFIR and involve semi-structured interviews with clinical staff, providers, and facility leaders in Year 4. Next Steps: The formative evaluation will set the investigators up for implementation studies to evaluate web-SUCCEED in a wider array of clinical settings and facilities. Existing operational partnerships will facilitate wider clinical implementation and moving research into practice. The innovative project, strong investigative team and operational partnerships will ensure a successful study that has the potential to shift clinical paradigms. ;
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