In order to develop SPIN programs, to test whether these programs work well in real life and to make them widely available, our team needs to recruit a large, multinational cohort of people with scleroderma. A cohort is a large group of people who share a set of similar characteristics or have lived the same experience (in this case, living with scleroderma), and who begin to participate in a research study or studies at the same time.
Individuals recruited into the SPIN cohort will help to develop and test supportive programs. They will then participate in several large clinical trials over the number of years. The trials will investigate how well the supportive programs work by comparing information collected from different groups of participants within the cohort. SPIN was awarded a 5-year Emerging Team Grant for Rare Diseases from the Canadian Institutes of Health Research in 2012 to help support its initiative. Recruitment sites from across Canada, the United States, and Europe have started to recruit scleroderma patients for the cohort in early 2013.
Online Supportive Programs.
Many people with scleroderma face daily challenges caused by their illness. Problems such as chronic fatigue, reduced hand function, visible changes in appearance, and other symptoms can make it difficult to manage daily tasks and participate in enjoyable activities. This may cause unnecessary stress and emotional problems, such as sadness, hopelessness, fear, or anger. The supportive programs that are currently being developed by SPIN aim to address these problems for people with scleroderma. These programs are psychosocial, because they help boost emotional well-being and nurture social ties. Their other aim is rehabilitation, as they purport to help managing symptoms and balancing daily activities. In short, the purpose of the online supportive programs is to improve the quality of life for people living with the disease.
Many programs of this type already exist. They are the result of extensive research and practice in medicine, psychology, occupational therapy and other disciplines. SPIN programs are largely based on already existing information and research. However, the novelty of SPIN programs is twofold. First, SPIN programs are tailored specifically for people with scleroderma. Second, all the programs are Internet-based, which increases accessibility for patients who live far from treatment centers, have mobility issues, or other barriers to treatment. Moreover, interactive technology is used in all Internet-based programs, making the information more accessible and easy to implement in real life.
Many people living with scleroderma attend support groups to cope with their illness. Support groups offer a safe and comfortable environment where people facing a similar challenge can come together to give and receive support. This kind of exchange can offer many personal and practical benefits, such as learning how others have dealt with issues related to scleroderma or learning more about current scleroderma research. Leaders of scleroderma support groups play an especially important role as they are in charge of the many tasks that go into running a successful support group meeting from coordinating administrative details to facilitating a meaningful group discussion.
The Scleroderma Support Group Team is comprised of researchers, members of Scleroderma Canada and the Scleroderma Foundation in the United States, and patient support group leaders. This team has come together to create the SPIN-Scleroderma Support group Leader EDucation (SSLED) Program. The goal of this 3-month training program is to provide leaders with information and resources to help them feel more comfortable, confident and supported in their roles, and in turn, contribute to a more positive support group experience for all those who attend.
Many people living with scleroderma are supported by a family member or a friend. Informal caregivers are family members or friends who provide unpaid care for a loved one with a health condition. This project focuses on better understanding challenges faced by informal caregivers of people living with scleroderma, and their preferences for types of support services that could potentially be developed. Our long-term goal is to develop interventions aimed at increasing overall quality of life for informal caregivers of those living with scleroderma.
The Scleroderma Caregiver Project Team is comprised of researchers and informal caregivers of people living with scleroderma. This team has collaborated to create an online survey to obtain information about the experience of informal caregivers of people with scleroderma. With this information, our goal is to develop resources that are tailored to meet the needs of caregivers of people with scleroderma.
It is important to know the degree of complexity involved in implementing the SPIN supportive programs, as well as in using them. SPIN will conduct feasibility testing for each of its programs. This will involve reviewing the process of implementing each program, required resources (including time and budget), management issues (personnel and data systems), and various scientific aspects of evaluating each program. Importantly, feasibility testing will include assessing how straightforward and engaging the programs are for people with scleroderma. This will be evaluated by conducting interviews with randomly selected study participants, in which questions about acceptability, utility and practicality of program components will be asked.
Based on the information obtained from feasibility testing, SPIN programs can be modified to better suit the needs of patients. On the side of program providers, the number of resources invested in each program can be optimized.
Randomized Controlled Trials (RCTs).
An important consideration for any supportive program is whether it reaches its goals. For SPIN, this means asking whether the program actually makes it easier for people with scleroderma to cope with the challenges posed by their illness. For instance, if a program is designed to help an individual feel less sad or anxious, how can we tell if the participation in the program does indeed reduce sadness or anxiety? A Randomized Controlled Trial (RCT) is a type of scientific study specifically designed to answer questions like these. In an RCT, participants are randomly assigned into two different groups – the group that receives the program and the group that does not. The groups are then compared on a characteristic that interests researchers (for example, do participants in the program group feel less sad compared to the participants in the no-program group after the program is finished?).
SPIN will use a particular variation of an RCT to determine whether the programs work for people with scleroderma. Thus, each participant in the SPIN study and in the SPIN cohort may be invited to participate in one of the RCTs currently being conducted by SPIN.
Dissemination of Programs.
Once the SPIN programs have been fully developed and tested, SPIN will make use of its partnerships with scleroderma patient organizations around the world to make these programs fully available for free to all people with scleroderma, not just those who have participated in the SPIN studies.