Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02897622
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2016-08-12
Brief Title:
Severe and Enduring Eating Disorder Patients at Stockholms Center for Eating Disorders in Sweden
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Severe and Enduring Eating Disorder Patients at Stockholms Center for Eating Disorders in Sweden
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEED
Brief Summary:
Patients with severe and enduring eating disorders SEED are seriously ill and have a low quality of life In 2014 a special unit based on case management CM for patients with SEED the Eira unit was started at Stockholm Centre for Eating Disorders Sweden Eating disorder is a serious illness that creates a great deal of suffering Most patients who undergo specialized eating disorder treatment will be healthy but a small percentage of the patients develop a SEED SEED patient have gone through numerous of treatments and has been to several specialists units for years as well as they has completed many different therapies without getting fee from the eating disorder ED Due to the long term sick in ED the SEED patient is often alone and has difficulties to cope with everyday life situations SEED patients are a vulnerable patient population with a great suffering and poverty to release the identity of the ED However no previous study is done in which patients with SEED themselves describe their own theory about why they are still ill and how specialized eating disorder care has affected them In the ED field there is a growing consensus that treatment of patients with SEED needs to be multi-professional with a focus on improving the patients social situation minimizing medical complications and enhancing quality of life and independence rather than focusing one-sided on symptom reduction Is case management a way to help the SEED patients witness a better quality of life Besides the personal suffering of patients and their families SEED is also associated with high costs for health care and for society in general
Detailed Description:
1 This is a qualitative study based on semi-structured interviews with 21 patients with SEED Grounded theory was used to analyse data The patients had suffered from eating disorders on average for 215 years with a BMI of 154 122-195 at the time for the interview
2 Methods for data collection are a semi-structured diagnostic interview a qualitative interview self-report questionnaires and data from medical records The diagnostic interview and the self-report assessments will be done at start of treatment and at follow-ups after one two and three years The qualitative interview will be conducted one year after start of treatment Data from medical records will be collected retrospectively
The Structured Eating Disorder Interview SEDI is a semi-structured diagnostic interview for ED diagnoses according to the DSM-IV The interview consists of a maximum of 30 and normally about 20-25 questions
The RAND-36 also known as the SF-36 measures health-related quality of life HRQoL Changes in the HRQoL over time can be seen by comparing repeated assessments
The Eating Disorder Examination Questionnaire EDE-Q measures central symptomatic aspects of ED by way of patients self-ratings
The Treatment Satisfaction Scale 2 TSS-2 is a patient-rated assessment of treatment satisfaction in a simple 6-item scale TSS-2 will be used at all follow-ups
The qualitative interview is semi-structured and consists of three broad themes
1 The patients thoughts about herhis life situation in the year heshe has been at Eira
2 The patients thoughts and reflections about herhis quality of life and whether it has been affected in the year heshe has been at Eira
3 The patients thoughts about herhis future The informants will be asked to talk openly around these themes The interviewer who is the same person for all interviews is a psychologist who is not part of the Eira staff
4 The cost-effectiveness analysis consists of costs of the CM intervention changes in quality of life as well as societal costs such as health care usage and loss of production The perspective of the analysis will be societal and the time horizon three years The analysis method is going to be cost-utility analysis with health effect expressed in quality adjusted life years QALY The analysis will be complemented with the probability of acceptable cost-effectiveness with different willingness to pay for a QALY
All costs of the CM intervention occur at Eira The cost for each patient in the study can be calculated by Eiras total cost divided with each patients share of resource utilization based on enrolled time
QALYs will be estimated based on RAND-36 transformed to SF-6D based on a British preference score From the measures at baseline and after 1 2 and 3 years changes in QALYs can be estimated From medical records changes in cost of health care usage can be calculated The participants employment and change acquisition work rate is followed during the same period based on interviews with participants
The treatment may also have impact on relatives quality of life costs and earnings These aspects will not be considered in the analysis
Setting
During the first 5-6 sessions at Eira the patients psychiatric somatic and social condition is carefully investigated as well as herhis medical history and previous treatment experiences Thereafter the CM intervention starts The patients needs and preferences guides where and how often the meetings take place and some can be done by phone or text messages Another important part of the CM is to help the patients contact the authorities and if necessary to aid them with economic issues
In addition to the supportive interventions is it also important to regularly monitor the somatic condition and the weight of the patients If the patient is temporarily in need of more somatic or psychiatric help the therapists can help in planning a short more intensive treatment
Twice a year there is a lecture about the SEED condition for the relatives without the patients at Eira During the lecture the relatives can ask questions and discuss problems they encounter as SEED relatives With the patients consent relatives are invited to participate in the CM treatment Information and support is offered relatives on an individual basis this also includes underage children
2 Methods for data collection are a semi-structured diagnostic interview a qualitative interview self-report questionnaires and data from medical records The diagnostic interview and the self-report assessments will be done at start of treatment and at follow-ups after one two and three years The qualitative interview will be conducted one year after start of treatment Data from medical records will be collected retrospectively
The Structured Eating Disorder Interview SEDI is a semi-structured diagnostic interview for ED diagnoses according to the DSM-IV The interview consists of a maximum of 30 and normally about 20-25 questions
The RAND-36 also known as the SF-36 measures health-related quality of life HRQoL Changes in the HRQoL over time can be seen by comparing repeated assessments
The Eating Disorder Examination Questionnaire EDE-Q measures central symptomatic aspects of ED by way of patients self-ratings
The Treatment Satisfaction Scale 2 TSS-2 is a patient-rated assessment of treatment satisfaction in a simple 6-item scale TSS-2 will be used at all follow-ups
The qualitative interview is semi-structured and consists of three broad themes
1 The patients thoughts about herhis life situation in the year heshe has been at Eira
2 The patients thoughts and reflections about herhis quality of life and whether it has been affected in the year heshe has been at Eira
3 The patients thoughts about herhis future The informants will be asked to talk openly around these themes The interviewer who is the same person for all interviews is a psychologist who is not part of the Eira staff
4 The cost-effectiveness analysis consists of costs of the CM intervention changes in quality of life as well as societal costs such as health care usage and loss of production The perspective of the analysis will be societal and the time horizon three years The analysis method is going to be cost-utility analysis with health effect expressed in quality adjusted life years QALY The analysis will be complemented with the probability of acceptable cost-effectiveness with different willingness to pay for a QALY
All costs of the CM intervention occur at Eira The cost for each patient in the study can be calculated by Eiras total cost divided with each patients share of resource utilization based on enrolled time
QALYs will be estimated based on RAND-36 transformed to SF-6D based on a British preference score From the measures at baseline and after 1 2 and 3 years changes in QALYs can be estimated From medical records changes in cost of health care usage can be calculated The participants employment and change acquisition work rate is followed during the same period based on interviews with participants
The treatment may also have impact on relatives quality of life costs and earnings These aspects will not be considered in the analysis
Setting
During the first 5-6 sessions at Eira the patients psychiatric somatic and social condition is carefully investigated as well as herhis medical history and previous treatment experiences Thereafter the CM intervention starts The patients needs and preferences guides where and how often the meetings take place and some can be done by phone or text messages Another important part of the CM is to help the patients contact the authorities and if necessary to aid them with economic issues
In addition to the supportive interventions is it also important to regularly monitor the somatic condition and the weight of the patients If the patient is temporarily in need of more somatic or psychiatric help the therapists can help in planning a short more intensive treatment
Twice a year there is a lecture about the SEED condition for the relatives without the patients at Eira During the lecture the relatives can ask questions and discuss problems they encounter as SEED relatives With the patients consent relatives are invited to participate in the CM treatment Information and support is offered relatives on an individual basis this also includes underage children
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