A Feasibility Study

1. Implementing a Modular Digital Intervention to Improve Mood and Adherence in Solid Organ Transplant Patients A Feasibility Study

2. Introduction Transplantation, Adherence, Psychosocial Factors, and Interventions

3. Overview of the solid organ transplant process • Background • Solid organ transplant operations include those involving the kidneys, pancreas, liver, intestine, heart, and lung. • As of 2008, there were over 27,000 solid organ transplants in the United States alone, with the most common operations involving the kidneys (ustransplant.org, 2012). • Rates of morbidity and mortality vary greatly depending on the organ or organs involved, with those receiving Kidney transplants fairing the best. • Recipients across organs in this group tend to experience roughly the same difficulties in terms of psychiatric difficulties and impact on quality of life (Fukunishi, 2002).

4. Overview of the solid organ transplant process • Background • Factors of importance when considering how the life of a solid organ transplant recipient will change after receiving their new organ: • Lifestyle change to compensate for the effects of transplant as well as avoid further complications (e.g. infection) • New physical limitations • Impact on social functioning • Medication adherence. • The extent to which one’s behavior is inline with physician prescriptions, non-adherence is considered 25% or greater deviations form the prescription. • Measured via levels of a medication in the blood, self-report, pill counts, or electronic medication monitors (Burra, Germani, Gnoato, Lazzaro, Russo, Cillo, & Senzolo, 2011) • Combing both objective and subjective measures may add some benefits in some populations (Pai et al, 2012).

5. Overview of the solid organ transplant process • Medical considerations • Recent advances in medicine have resulted in greater immediate survival rates in solid organ transplant patients. • Regimens have become more complex. • Face-to-face time with medical staff is at a premium. • Psychosocial considerations and Outcomes • Long term psychosocial functioning is less promising (Lodhi, Lamb, & Meier-Kriesche, 2011). • Depression and anxiety are among the most common conditions following organ transplantation, with depression occurring between 5-25% of patients and anxiety in between 17 and 28% (Heinrich and Marcangelo, 2009). • Evidence of a relationship between transplantation and diminished quality of life (Ortega, Covadonga, & Ortega, 2007). • These conditions can impact the physiological wellbeing of patients.

6. Issues Related to Regimen Adherence • Lifestyle changes and Medication adherence • Poor adherence is often problematic and leads to negative overall outcomes (Chisholm, 2002). • Up to 25% of deaths following transplantation can be attributed to lack of adherence. • A primary factor impacting adherence includes psychiatric difficulty both before and after translation (Heinrich and Marcangelo, 2009).

7. Issues Related to Regimen Adherence • Issues of Adherence Chisholm (2002) • The number of medications many solid organ transplant patients are required to take. • Many of these medications need to be taken multiple times a day and/or at different times from one another, which often leads to confusion and inadvertent non-adherence. • Expected side effects those expecting a number of negative side effects have been shown to be less adherent than those unaware • Presence of psychiatric symptoms, including depression. • Cukor (2008) - Those receiving kidney transplants were less likely to adhere to the regiment laid out by their physicians than those not experiencing depression. Similar findings were reported by Burra, et al (2011) when studying liver transplant recipients..

8. Issues Related to Mood • Depression • Risk factors include not having a regular income, not having desired the transplant, and experience of a rejection episode. • Tsunoda, Yamashita, and Kojima (2009): Depression in transplant patients is rooted in and maintained by a complex set of interacting factors, one of the strongest being poor social functioning and follow-up with medical staff. • Even transplant patients who have relatively successful operations with few to no complications are still found to experience depression, which some have labeled a paradoxical depression (H. Sugawara, K. Nishimura, S. Kobayashi, H. Ishida, K. Tanabe, J. Ishigooka, 2008). • Savitch, Gilmore, & Dowler (2003) - support groups are an additional source of information, commiseration, education, socialization, advocacy, and support after transplantation all of which serve to protect against the negative impact of depression and are linked to overall improve quality of life.

9. Issues Related to Mood • Depression • Thompson, and Lambros (2010)- Interventions targeting improved subjective perception of health, learning to cope with pain experiences, mediating stress levels, enhancing independence and capacity to meet responsibility, facilitating access to and use of health care, and attributing a personal sense of value and usefulness to others will also lead to overall positive outcomes, including increase adherence, quality of life, and, as such, lower incidence of depression. • Depression is significantly correlated with maladaptive coping strategies in some transplant patients (Burker, Evon, Marroquin, Finkel, & Mill, 2005). • Kugler, et al (2009) suggest that a patients' appraisal of symptoms and side-effects related to the immunosuppressive therapy will lead to, among other things, improving Health Related Quality of Life by mitigating the various factors with negative transplant experience.

10. Existing Interventions • "Standard" individual and group interventions in use today • Kempf (1967) suggested that an important focus for improving overall outcome was to introduce psychotherapeutic interviews in the immediate post-transplant period in an effort to move patients toward setting realistic expectations and fostering hope. • Miller, et al (2002) suggest a combination of interposal therapy and psychopharmacological interventions can address goals similar to those described by Kempf, however it should be noted that the work presented by Miller was a single case study and requires additional investigation. • Baines (2004) suggests that both individual and group interventions can be effective in addressing depression in transplant patients, with individual therapy showing a slightly greater effectiveness in specifically lower scores on the Beck Depression Inventory (BDI-II). • Griffith (2005) suggests bedside psychotherapy can counter helplessness and sense of isolation, factors associated with depression and poor adherence, that many patients experience when affected by illness and its treatments.

11. Existing Interventions • "Standard" individual and group interventions in use today • Kaba (2000) offers suggestions for positive coping strategies which, as previously described, are imperative in mitigating the onset and maintenance of depression in this population. The authors suggest focusing interventions on addressing acceptance and optimism, denial and avoidance, setting targets, comparing oneself with others, making attributions, seeking social support, having faith and changing priorities and perceptions. • Chisholm (2002): an important starting point in any intervention can be grounded in the Health Belief Model and Health Decision Model. Taken together, these models for improving adherence suggest that the probability that medical advice will be adhered to is a function of the patient's perception of their disease susceptibility and severity as well as benefits, adverse experiences, and barriers likely to be encountered as a result of the recommended action. • Raiz, et al (1999) suggest that modifying an helping an individual understand their locus of control over their condition, as well as respecting their wishes, will lead to increased adherence. To summarize this approach, patient motivation will be linked to access to information, acquisition and internalization of information, and skills built from that information in determining the degree to which they are likely to adhere to their treatment regimen.

12. Existing Interventions • "Standard" individual and group interventions in use today • Lisson, et al (2005) offer a specific intervention to improve adherence by addressing specific barriers. This model suggests that the primary focus should be fostering a sense of self-control, self-evaluation, and self-correcting behaviors through interactive, didactic lessons. • De Bleser, et al (2008) suggest that while studies of interventions to improve adherence to medical regimens in solid organ transplant recipients are scarce there are a number of studies to which clinicians may look for guidance. • Nezu (2002) suggest Problem-Solving Therapy is an effective framework for reducing depression and improving overall quality of life. By working with the patient to determine their beliefs about their own ability to solve problems such as depression, as well as the degree to which they perceive challenges related to their transplant and overall health as solvable problems, this therapy seeks to help modify the patient’s orientation toward these difficulties and take a rational, step-wise approach to improving their mood, social functioning, and health behaviors.

13. Reasons a the current intervention is needed • Summary • There is no one way to tackling the challenges facing transplant patients and, a well refined, multimodal approach is warranted. • One effective way in which these interventions can be combined and monitored is via the integration of new and emerging technologies, such as web and mobile applications. • What has been done in terms of online interventions, why they have fallen short, and how this study addresses them? • Health-E-Vet • Zora

14. Purpose of the Present Study Feasibility, Adherence, and Symptom Remission

15. Feasibility • To assess the feasibility of delivering psychosocial interventions to solid organ transplant patients via the Internet.

16. Adherence • To determine if the current approach improves regimen adherence as well as or better than existing interventions.

17. Mood • To determine if the current approach improves issues of depression and anxiety as well as or better than existing interventions.

18. Social Component • To determine if the current approach improves perceived social support as well as or better than existing interventions.

19. Methods System Description, Recruitment, Measures

20. System Design • Education • “Lesson of the Week” format with options to click through to full lessons. • Brief Intervention • Test the users on what they’ve learned and how they will implement the lessons. • Communication • A moderated format, live chat session at pre-scheduled times. • A place where patients can journal notes for their care team. • Emphasis on this not being used for urgent issues. • Planning • Calendars and Agenda loaded with times for medication and appointments with care team. • Reminders sent via E-mail, text, or both.

21. Data Security • Enforcement of strong passwords • Data encryption

22. Recruitment • From local transplant programs • 18 years and older • Recruited in person • Willing participants will have accounts created on site • Other criteria • Have had a transplant within the last 2 years. • Can communicate effectively in English • Committing for six-months • Tutorial • A tutorial will be given at recruitment and will be available online.

23. Measures • Feasibility • Objective Measures • Examining server logs regarding how many times the individuals logged on, how long they remained logged on, and what they clicked. • Retention • Subjective Measures • Questionnaire completed at the completion of the study regarding what they found useful and not useful. • Demographic Questionnaire • Medication Adherence • Morisky Medication Adherence Scale (MMAS-8) • Depression and Anxiety • Depression Anxiety Stress Scales (DASS) • Timing • All measures will be administered at baseline, a 3 months, and at six months.

24. Design and Proposed Analysis of Results

25. Proposed Analysis of Results • Descriptive information will be examined regarding website accessibility and user opinions. • Analysis of variance (ANOVA) will be used to examine patient changes in continuous variables • Mean psychiatric symptom levels and adherence from the pre- to post • For each measure, a 1 X 2 (time: pre-post) repeated-measures analysis of variance (ANOVA) will be performed. • Hypothesis: Based on health psychology theories, the current interventions will increase planned behaviors and, thus, increase adherence. Increase adherence and social connectedness will improve measures of psychiatric symptoms.