Peer Support for Inflammatory Bowel Disease Distress

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jennifer Jones

No Placebo Group

Trial Summary

What is the purpose of this trial?

Psychological distress (PD) as a result of inflammatory bowel disease (IBD) is prevalent and associated with worse disease-related outcomes. IBD-associated psychological distress (IBD-PD) is particularly common at initial diagnosis, during disease flares, before surgery, and during transitions of care. Access to evidence-based, gold-standard psychological interventions and emotional support for IBD-PD has been identified as a major care gap by persons living with IBD. The COVID-19 pandemic has further exacerbated the burden of PD for persons living with chronic diseases like IBD, predisposing at-risk individuals to even greater mental struggles. Studies have shown a minority of patients are asked about IBD-PD in routine clinical care and that even if asked, access to mental health care is extremely limited. iPeer2Peer is an evidence-based, peer-led, virtually administered intervention for IBD-PD in the pediatric population that has demonstrated feasibility, acceptability and early effectiveness. Using qualitative data derived from an extensive stakeholder engagement process, iPeer2Peer has been adapted to meet the needs of adults living with IBD-PD. This program, IBD Strong Peer, will be studied through a randomized, wait list-controlled hybrid implementation-effectiveness trial in Nova Scotia. This study will provide implementation data needed to improve and adapt the intervention and implementation strategy to meet local needs, as well as provide early effectiveness data. This data will inform the design and statistical power needed for future larger, multicenter randomized control trials. IBD Strong Peer has significant potential to improve access to evidence-informed interventions for IBD-PD.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants can be in a period of changing medications, so it might be possible to continue your current treatment.

What data supports the idea that Peer Support for Inflammatory Bowel Disease Distress is an effective treatment?

The available research shows that the IBD Connect program, which involves peer volunteers visiting hospitalized patients with IBD, has been effective in reducing stress related to hospitalization. Patients reported a significant decrease in stress and were more willing to share their experiences with family and friends. This suggests that peer support can be a valuable part of managing IBD, especially in a hospital setting, by providing emotional support and encouraging open communication. ^{1 2 3 4 5}

What safety data exists for peer support treatment in IBD?

The provided research does not contain specific safety data for peer support treatments like IBD Strong Peer2Peer, IBD Strong Peer, or iPeer2Peer. The studies focus on other aspects of IBD management, such as treatment patterns, biologic therapies, and management in older adults. ^{6 7 8 9 10}

Is the treatment IBD Strong Peer2Peer a promising treatment for people with inflammatory bowel disease?

Yes, IBD Strong Peer2Peer is a promising treatment for people with inflammatory bowel disease. It offers emotional support and helps people learn coping strategies from others who have the same condition. This kind of peer support can improve how people manage their disease and make them feel better emotionally. ^{4 11 12 13 14}

Research Team

Eligibility Criteria

This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who are newly diagnosed, switching from child to adult care, experiencing a flare-up or medication change, recently hospitalized, or preparing for surgery. It's not suitable for those outside these criteria.

Inclusion Criteria

I am 18 or older with inflammatory bowel disease.

I am newly diagnosed or currently adjusting my care or treatment plan.

Treatment Details

Interventions

• IBD Strong Peer2Peer (Behavioral Intervention)

Trial Overview The IBD Strong Peer2Peer program is being tested against a waitlist control group. This peer-led virtual support aims to help manage psychological distress in adults with IBD. The study will gather data on how well it works and how it can be improved.

Participant Groups

Group I: Waitlist -controls Experimental Treatment 1 Intervention

Group II: IBD Strong Peer2Peer intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jennifer Jones

Lead Sponsor

Trials

3

Recruited

300+

Crohn's and Colitis Canada

Collaborator

Trials

8

Recruited

1,300+

Nova Scotia Health Authority

Collaborator

Trials

302

Recruited

95,300+

Karen Oldfield

Nova Scotia Health Authority

Chief Executive Officer since 2021

Past Chair of the Board of Governors of Saint Mary’s University

Dr. Robert Strang

Nova Scotia Health Authority

Chief Medical Officer

MD

Findings from Research

The IBD Connect program, which involves peer volunteers providing emotional support to hospitalized patients with inflammatory bowel disease (IBD), has successfully made 1469 visits to 677 patients since its launch in 2012, demonstrating its feasibility and positive reception.

Patients reported a significant decrease in stress related to hospitalization and an increased willingness to share their IBD experiences with family and friends, highlighting the importance of peer support in enhancing patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory Bowel Disease (IBD) Connect: A Novel Volunteer Program for Hospitalized Patients with IBD and Their Families. Hashash, JG., Sigal, R., Wein-Levy, P., et al.[2019]

In a study of 408 inflammatory bowel disease (IBD) patients, those living closer to specialist centers (within 10 km) received more aggressive treatments, such as anti-TNF agents and corticosteroids, compared to those living further away (over 35 km).

Despite differences in treatment based on distance to specialists, the overall disease course and need for surgeries did not vary significantly among the different distance groups, suggesting that while access may influence treatment choices, it does not necessarily impact long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of distance to specialist care for the diagnosis and disease outcome of inflammatory bowel disease in the Swiss inflammatory bowel disease cohort study. Grob, L., Bluemel, S., Biedermann, L., et al.[2022]

The Crohn's and Colitis Foundation of America Partners Patient-Powered Research Network (PPRN) aims to enhance research in inflammatory bowel diseases (IBDs) by utilizing patient-generated health data to inform and prioritize research agendas.

This network has established a community of 'citizen scientists' and developed a robust infrastructure to facilitate patient engagement in research, ultimately aiming to improve health outcomes for individuals with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn's and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners). Chung, AE., Sandler, RS., Long, MD., et al.[2022]

Participation in online support communities for inflammatory bowel disease (IBD) significantly enhances patients' access to information and emotional support, helping them manage their condition and improve their overall wellbeing.

While these communities offer valuable benefits, such as fostering a positive outlook on illness, they also have limitations that healthcare professionals should recognize when advising patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do online patient support communities affect the experience of inflammatory bowel disease? An online survey. Coulson, NS.[2022]

A pilot study involving 15 participants showed that using patient-reported outcomes measures (PROMs) through an electronic platform for self-management in IBD care was well-accepted, with 10 participants feeling 'well' or 'well with questions'.

The implementation of PROMs in outpatient settings allowed for real-time tracking of quality of life and disease activity, enabling remote management of well patients and potentially increasing efficiency in outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. Avery, P.[2022]

The prevalence of inflammatory bowel disease (IBD) is rising among older adults, particularly those over 60, yet this group is often underrepresented in clinical trials, leading to inconsistent care and high rates of corticosteroid use.

Effective management of IBD in older adults requires a personalized approach that considers individual risks, comorbidities, and the need for better research on treatment efficacy and safety tailored to this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of inflammatory bowel diseases in older adults. Singh, S., Boland, BS., Jess, T., et al.[2023]

In a study of 1032 IBD patients in Germany, about one-third were not in clinical remission, highlighting a significant burden of active disease despite high rates of immunosuppressive drug use.

The study found that 15% of patients reported depressive symptoms and 21% experienced impairments in sexuality, indicating that IBD is associated with considerable psychosocial challenges alongside physical health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical status, psychosocial impairments, medical treatment and health care costs for patients with inflammatory bowel disease (IBD) in Germany: an online IBD registry. Bokemeyer, B., Hardt, J., Hüppe, D., et al.[2016]

In a study of pediatric patients with ulcerative colitis (UC) and Crohn's disease (CD) over 3 years, the use of corticosteroids decreased while the use of anti-TNF biologics and other immunosuppressants increased, indicating a shift towards more targeted therapies.

The initial maintenance doses of biologics like infliximab and adalimumab were found to be significantly higher than standard dosing guidelines, suggesting a need for further evaluation of dosing practices in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn's disease. Hunter, T., Komocsar, WJ., Colletti, RB., et al.[2023]

In a study of 2906 individuals with potential inflammatory bowel disease (IBD) diagnoses from computerized data, 81% were confirmed to have IBD through chart review, indicating a high level of accuracy in the computerized data.

By requiring two or more visits for diagnosis, the positive predictive value (PPV) of identifying true IBD cases increased to 95%, demonstrating that computerized data can be reliably used for research on drug safety and treatment efficacy in IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of computerized diagnoses, procedures, and drugs for inflammatory bowel disease in a northern California managed care organization. Liu, L., Allison, JE., Herrinton, LJ.[2022]

In a study of 95 patients over 65 years old with inflammatory bowel disease (IBD) treated with TNF inhibitors, 11% experienced severe infections and 10% died, indicating a higher risk compared to younger patients.

The findings suggest that older patients on TNF inhibitors have a significantly increased rate of severe infections and mortality compared to both younger patients and older patients treated with other medications, highlighting the need for further research on the safety of these therapies in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced age is an independent risk factor for severe infections and mortality in patients given anti-tumor necrosis factor therapy for inflammatory bowel disease. Cottone, M., Kohn, A., Daperno, M., et al.[2022]

A systematic review of 14 studies on peer support interventions for people with inflammatory bowel diseases (IBD) found no significant evidence that these interventions improve quality of life or psychosocial outcomes, indicating a need for more focused research.

Most studies included peer support as part of broader interventions, making it difficult to isolate its specific effects; future randomized controlled trials should aim to evaluate peer support independently to better understand its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support for carers and patients with inflammatory bowel disease: a systematic review. Adriano, A., Thompson, DM., McMullan, C., et al.[2022]

Peer support interventions for adolescents and young adults (AYAs) with inflammatory bowel disease (IBD) are promising and can enhance self-management, but there is currently limited research on this topic, with only two studies identified.

An innovative mobile-based peer coaching program was developed, demonstrating the potential to effectively support AYAs with IBD in managing their condition and promoting positive behavioral changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of a Peer Coaching Intervention to Enhance Self-Management for Adolescents and Young Adults With Inflammatory Bowel Disease. Pollock, MD., Brotkin, SM., Denio, E., et al.[2023]

Out of 2084 patients with inflammatory bowel disease (IBD) invited to join a self-help group, only 138 (7%) actually joined, with higher participation rates among women and those with Crohn's disease.

Respondents indicated that the self-help group was valuable for providing information, mutual support, and opportunities to discuss issues, with 99% finding the general information useful, although many non-joiners cited reasons like being too busy or managing without support as barriers to participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disinterest in local self-help groups amongst patients with inflammatory bowel disease in Leicester. Moody, GA., Bhakta, P., Mayberry, JF.[2019]

A peer mentoring program for youth with inflammatory bowel disease (IBD) was developed based on focus group feedback from 36 participants, including youth and parents, emphasizing the importance of support, role modeling, and education.

The proposed program includes a year-long, one-on-one mentoring relationship with peers who have IBD, along with educational and fun activities, which aligns with successful mentoring practices and aims to enhance self-management skills in pediatric IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focus groups for developing a peer mentoring program to improve self-management in pediatric inflammatory bowel disease. Mackner, LM., Ruff, JM., Vannatta, K.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Inflammatory Bowel Disease (IBD) Connect: A Novel Volunteer Program for Hospitalized Patients with IBD and Their Families. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effect of distance to specialist care for the diagnosis and disease outcome of inflammatory bowel disease in the Swiss inflammatory bowel disease cohort study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn's and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners). [2022]

4. England pubmed.ncbi.nlm.nih.gov

How do online patient support communities affect the experience of inflammatory bowel disease? An online survey. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Management of inflammatory bowel diseases in older adults. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Clinical status, psychosocial impairments, medical treatment and health care costs for patients with inflammatory bowel disease (IBD) in Germany: an online IBD registry. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn's disease. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Validity of computerized diagnoses, procedures, and drugs for inflammatory bowel disease in a northern California managed care organization. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Advanced age is an independent risk factor for severe infections and mortality in patients given anti-tumor necrosis factor therapy for inflammatory bowel disease. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Peer support for carers and patients with inflammatory bowel disease: a systematic review. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Clinical Application of a Peer Coaching Intervention to Enhance Self-Management for Adolescents and Young Adults With Inflammatory Bowel Disease. [2023]

13. Germany pubmed.ncbi.nlm.nih.gov

Disinterest in local self-help groups amongst patients with inflammatory bowel disease in Leicester. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Focus groups for developing a peer mentoring program to improve self-management in pediatric inflammatory bowel disease. [2021]