- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07350720
Inpatient Care of Patients With Difficult to Treat Anorexia Nervosa - Factors Affecting Treatment Outcome.
Inpatient Care of Patients With Difficult to Treat Eating Disorders - What Affects Treatment Outcome?
The overall aim of the project is to investigate factors that may influence treatment outcomes in people with difficult-to-treat anorexia nervosa who are enrolled in inpatient care at the Region Skåne Eating Disorders Centre in Lund. Treatment expectations, sense of autonomy, and patient participation, will be investigated, as well as caregivers' attitudes towards, and experiences of working with, autonomy and patient participation in the inpatient setting. The research project is expected to contribute to increased knowledge about the treatment of difficult-to-treat anorexia nervosa, and what part patient participation and autonomy may play when treating severe eating disorders. The overall objectives of the research program are:
- To contribute to increased knowledge about factors that influence the treatment of people with difficult-to-treat anorexia nervosa
- To highlight the role of autonomy and patient participation in inpatient care of severe eating disorders
- To use the research results for clinical improvement work at Region Skåne Eating Disorders Center
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emelia Mellergård, PhD
- Phone Number: +46709407381
- Email: emelia.mellergard@skane.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Anorexia Nervosa diagnosis (ICD F50.0)
- Admitted to inpatient care at department 5 at Region Skåne Eating Disorders Center
Exclusion Criteria:
- Confidential identity
- Inability to read or write in Swedish or English
- Condition or treatment that, according to the study team, makes participation in the study inappropriate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: BMI will be calulated on a weekly basis throughout the inpatient treatment period, and baseline measures until end of treatment/discharge from inpatient unit at approximately 12 weeks will be used for analysis.
|
BMI is calculated using weight and height: weight (kg) / (height (m) x height (m))
|
BMI will be calulated on a weekly basis throughout the inpatient treatment period, and baseline measures until end of treatment/discharge from inpatient unit at approximately 12 weeks will be used for analysis.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment satisfaction
Time Frame: CSQ-8 is collected at the end of treatment/at discharge from inpatient care at approximately 12 weeks as well at 1 year follow-up after discharge, in order to evaluate the treatment given.
|
Satisfaction with treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8), which contains 8 items.
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
|
CSQ-8 is collected at the end of treatment/at discharge from inpatient care at approximately 12 weeks as well at 1 year follow-up after discharge, in order to evaluate the treatment given.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emelia Mellergård, PhD, Region Skåne VO Vuxenpsykiatri Lund
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-07313-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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