protocolSection identificationModule nctId: NCT06309316, orgStudyIdInfo id: Grace-PCC, briefTitle: The Impact of Person Centred Care (PCC) in Grave's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will:WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality.WP2 Investigate the cost-effectiveness of the interventionPatients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness., conditionsModule conditions: Graves Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Person-centred care (PCC), outcomesModule primaryOutcomes measure: Composite score of changes, secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Composite score of changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Agneta Lindo, status: RECRUITING, city: Göteborg, zip: 413 45, country: Sweden, contacts name: Agneta Lindo, role: CONTACT, phone: +4676-6185481, email: agneta.lindo@vgregion.se, contacts name: Helena Filipsson Nyström, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False