Ignite Creation Date:
2024-05-06 @ 8:14 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02694042
Status:
TERMINATED
Last Update Posted:
2019-03-01
First Post:
2015-08-25
Brief Title:
Mission is Remission How Can a Disease Self-management Website Change Care
Sponsor:
IWK Health Centre
Organization:
IWK Health Centre
Study Overview
Official Title:
Mission is Remission How Can a Disease Self-management Website Change Care
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment challenges and lack of intervention engagement by participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns disease and ulcerative colitis known together as inflammatory bowel disease IBD are chronic inflammatory conditions of the gastrointestinal tract Impacts of IBD such as frequent hospital visits need for surgery and poor growth can significantly impact a childs social and academic life Dealing with a chronic disease forces children to rely more heavily on family members for coping strategies to deal with stress However a lot of families do not have the resources emotional or financial to provide the level of support needed A self management site called Mission is Remission has been created to help adolescents and their families deal with the stressors associated with their disease The site provides a supportive social network that is centred around learning sessions and active forums discussing topics related to disease self-management and coping This site actively brings together members of the healthcare team and provides support to families who might not be able to travel for additional appointments outside of routine care The goal of our research is to understand whether the changes this social support will increase disease-specific knowledge medication adherence and health-related quality of life We will also examine whether these changes may reduce some of the demands placed on the Health Care system eg reduced number of calls and visits to gastroenterology GI doctors or time lost from schoolwork In addition this website has been designed to be adapted in the future to other chronic diseases and will help bring healthcare into the digital age
Detailed Description:
Background How do health care professionals help children help themselves How do patients become active participants in their own care The prevalence of chronic conditions such as IBD is increasing in Canada 1 2 Health care systems need to look for sustainable and effective solutions to improve patient care while reducing health care costs Crohns disease CD and ulcerative colitis UC known collectively as IBD are chronic relapsing and remitting diseases associated with significant medical ie number of hospitalizations frequent need for surgery growth failure and social ie school absences interference with pursuit of higher education morbidity 3 Medical and social morbidity of IBD are intertwined and take a significant toll on the health-related quality of life HRQOL of these patients 4-6
IBD manifests during childhood or adolescence in 20 to 25 of patients 7 This is a crucial time in childrens development both physically 8 and emotionally 9 Childrens relationships with family and peers change significantly over the course of their childhood Normal social development sees children seeking more emotional support from peers over family members in their adolescent years 10 However adolescents with IBD do not follow this pattern 11 and tend to seek continued support from family members and rely on parents coping strategies to deal with stressors 12 With increased reliance on family support when dealing with a chronic illness like IBD children may be faced with additional burden when their parents are not able to offer them the emotional support they need or do not have coping skills that are effective enough to translate into increased care for their children Despite this no interventions to the authors knowledge to benefit psychosocial functioning have been specifically studied in pediatric patients or families with IBD
Current medical intervention tends to focus exclusively on the disease and does not focus on disease management and coping through self-management skills Disease self-management involves -the interaction of health behaviours and related processes that patients and families engage in to care for a chronic disease 13 Studies in both the adult and pediatric chronic illness literature have shown that comprehensive interventions that augment medical treatments with self management therapy lead to better medical outcomes and better quality of life than care that is strictly medically focused 4-6 14-24 These self-management studies are focused on chronic diseases such as diabetes asthma and rheumatoid arthritis There have been several small studies of psychological interventions in adult IBD patients with promising results though issues with design limited the interpretation of the results 25-28 Disease self-management is more than simple adherence to treatment guidelines - it also incorporates psychological and social management of living with a chronic illness
-Its something the investigators know intuitively but its also supported by evidence A childs living conditions and experiences - the determinants of health - shape his or her physical health development and well-being affecting not only childhood but the foundation of their health as adults 29 30 Stepping it up Report pg 23 Health Council of Canada
Childrens experiences ie access to services can be directly affected through disease self-management Self-management training is often provided by tertiary care clinics which includes disease education and encouragementsupport usually at the time of diagnosis Most care is given in concentrated sessions during crises times and is in response to a particular problem which is not the best time to teach self-management skills Families who are extremely distressed may in rare cases receive formal psychological therapy Although most families receive excellent medical care in the tertiary care centres the vast majority of patients do not receive comprehensive disease education and self-management therapy Very few children with IBD receive comprehensive education and self management therapy even when they attend well organized tertiary care clinics
Geographic and financial concerns often limit access to psychosocial care and information sessions In most areas of Canada psychosocial treatment is available through private care Psychosocial treatment is available for free through public institutions Canada Health Act 1984 however there are long waiting lists and significant time and financial-costs to patients Parents would have to travel and take time from work while children would miss school and other related activities which may further prevent access to treatment Many families are reluctant to see a psychologist social worker or psychiatrist due to the social stigma attached to seeking psychotherapy For some families the entire process is perceived as blaming them for their problems 31
In the past 20 years treatments aimed at teaching parents and children to change their attitudes or behaviour have been developed and evaluated by means of rigorous randomized trials 32-41 Although there is strong evidence that these psychosocial treatments work in reducing symptoms and increasing health related quality of life HRQOL they are typically delivered only in specialty clinics by highly trained personnel Few therapists outside of GI clinics will be knowledgeable enough about the disease to effectively help patients and families integrate their psychological and medical care Evidence from a large meta-analysis has shown that many self-management treatments can be given with as good or better outcomes by paraprofessionals following evidence-based protocols 42 The use of web-based programs to deliver self-management care has taken off in recent years Recent meta-analyses have found improved behavioural outcomes for adults using web-based self-management programs 43 and improvements in symptom and disease control for youth with health conditions 44 Web-based interventions have been found to be comparable to face-to-face treatments 45 and have demonstrated increased social support when programs utilize chat rooms As Stinson et al 44 state many studies have not been able to determine the durability of treatment effects or the cost-effectiveness of these programs The current research will attempt to address some of these shortcomings
Based on the lack of access to disease-specific care outside of existing medical intervention the Mission is Remission web-based intervention program was created in 2005 as a pilot study for use by IBD patients and their families This is a web-enabled evidence based home program of self-management information and social support for pediatric IBD patients aged 12-18 with a separate site for their parents The site was accessed on a restricted-access web site and participants worked through the program with help of a coach The coaches worked in collaboration with gastroenterologists nurses and a psychologist but the coaches were not medical professionals This served as an adjunct to routine medical care but not as prescribed medical therapy by the patients physician or team This individualized interactive 12 session program incorporated multi-media tools for disease education and psychological interventions
The previous research program enrolled two groups of patients-those with inactive disease and those with active disease and their parents 46 Remission was induced in patients with active disease before beginning use of the Mission is Remission site Although participants demonstrated improvements in main outcome variables such as HRQOL and Disease Knowledge there was no true control group in this study such that statements around the effectiveness of the program in comparison to routine or standard care could not be made Based on lessons learned from the first Mission is Remission site a new site was created which was made possible from an IWK Auxiliary Grant The expertise of the web-developer who has been involved in the development of multiple sites for teens was pivotal in guiding the sites development The use of social networking peer support and parent-to-parent support was optimized through this process
The proposed research plans to randomize patients to receive either comprehensive care using the Mission is Remission site or to receive routine care ie regular hospital clinic visits appointments with clinicians and other specialists as required
IBD manifests during childhood or adolescence in 20 to 25 of patients 7 This is a crucial time in childrens development both physically 8 and emotionally 9 Childrens relationships with family and peers change significantly over the course of their childhood Normal social development sees children seeking more emotional support from peers over family members in their adolescent years 10 However adolescents with IBD do not follow this pattern 11 and tend to seek continued support from family members and rely on parents coping strategies to deal with stressors 12 With increased reliance on family support when dealing with a chronic illness like IBD children may be faced with additional burden when their parents are not able to offer them the emotional support they need or do not have coping skills that are effective enough to translate into increased care for their children Despite this no interventions to the authors knowledge to benefit psychosocial functioning have been specifically studied in pediatric patients or families with IBD
Current medical intervention tends to focus exclusively on the disease and does not focus on disease management and coping through self-management skills Disease self-management involves -the interaction of health behaviours and related processes that patients and families engage in to care for a chronic disease 13 Studies in both the adult and pediatric chronic illness literature have shown that comprehensive interventions that augment medical treatments with self management therapy lead to better medical outcomes and better quality of life than care that is strictly medically focused 4-6 14-24 These self-management studies are focused on chronic diseases such as diabetes asthma and rheumatoid arthritis There have been several small studies of psychological interventions in adult IBD patients with promising results though issues with design limited the interpretation of the results 25-28 Disease self-management is more than simple adherence to treatment guidelines - it also incorporates psychological and social management of living with a chronic illness
-Its something the investigators know intuitively but its also supported by evidence A childs living conditions and experiences - the determinants of health - shape his or her physical health development and well-being affecting not only childhood but the foundation of their health as adults 29 30 Stepping it up Report pg 23 Health Council of Canada
Childrens experiences ie access to services can be directly affected through disease self-management Self-management training is often provided by tertiary care clinics which includes disease education and encouragementsupport usually at the time of diagnosis Most care is given in concentrated sessions during crises times and is in response to a particular problem which is not the best time to teach self-management skills Families who are extremely distressed may in rare cases receive formal psychological therapy Although most families receive excellent medical care in the tertiary care centres the vast majority of patients do not receive comprehensive disease education and self-management therapy Very few children with IBD receive comprehensive education and self management therapy even when they attend well organized tertiary care clinics
Geographic and financial concerns often limit access to psychosocial care and information sessions In most areas of Canada psychosocial treatment is available through private care Psychosocial treatment is available for free through public institutions Canada Health Act 1984 however there are long waiting lists and significant time and financial-costs to patients Parents would have to travel and take time from work while children would miss school and other related activities which may further prevent access to treatment Many families are reluctant to see a psychologist social worker or psychiatrist due to the social stigma attached to seeking psychotherapy For some families the entire process is perceived as blaming them for their problems 31
In the past 20 years treatments aimed at teaching parents and children to change their attitudes or behaviour have been developed and evaluated by means of rigorous randomized trials 32-41 Although there is strong evidence that these psychosocial treatments work in reducing symptoms and increasing health related quality of life HRQOL they are typically delivered only in specialty clinics by highly trained personnel Few therapists outside of GI clinics will be knowledgeable enough about the disease to effectively help patients and families integrate their psychological and medical care Evidence from a large meta-analysis has shown that many self-management treatments can be given with as good or better outcomes by paraprofessionals following evidence-based protocols 42 The use of web-based programs to deliver self-management care has taken off in recent years Recent meta-analyses have found improved behavioural outcomes for adults using web-based self-management programs 43 and improvements in symptom and disease control for youth with health conditions 44 Web-based interventions have been found to be comparable to face-to-face treatments 45 and have demonstrated increased social support when programs utilize chat rooms As Stinson et al 44 state many studies have not been able to determine the durability of treatment effects or the cost-effectiveness of these programs The current research will attempt to address some of these shortcomings
Based on the lack of access to disease-specific care outside of existing medical intervention the Mission is Remission web-based intervention program was created in 2005 as a pilot study for use by IBD patients and their families This is a web-enabled evidence based home program of self-management information and social support for pediatric IBD patients aged 12-18 with a separate site for their parents The site was accessed on a restricted-access web site and participants worked through the program with help of a coach The coaches worked in collaboration with gastroenterologists nurses and a psychologist but the coaches were not medical professionals This served as an adjunct to routine medical care but not as prescribed medical therapy by the patients physician or team This individualized interactive 12 session program incorporated multi-media tools for disease education and psychological interventions
The previous research program enrolled two groups of patients-those with inactive disease and those with active disease and their parents 46 Remission was induced in patients with active disease before beginning use of the Mission is Remission site Although participants demonstrated improvements in main outcome variables such as HRQOL and Disease Knowledge there was no true control group in this study such that statements around the effectiveness of the program in comparison to routine or standard care could not be made Based on lessons learned from the first Mission is Remission site a new site was created which was made possible from an IWK Auxiliary Grant The expertise of the web-developer who has been involved in the development of multiple sites for teens was pivotal in guiding the sites development The use of social networking peer support and parent-to-parent support was optimized through this process
The proposed research plans to randomize patients to receive either comprehensive care using the Mission is Remission site or to receive routine care ie regular hospital clinic visits appointments with clinicians and other specialists as required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None