Clinical trial NCT06309316: The Impact of Person Centred Care (PCC) in Grave's Disease
Official title: The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graves Disease
Keywords: Person Centred Care
Mental fatigue
cost-effectiveness
self-efficacy
eHealth
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-03-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 intervention

Patients 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.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* First time Graves' diseases with elevated FT4 and/or FT3 and positive TSH receptor antibody (TRAb)

Exclusion Criteria:

* Patients that cannot attend to the protocol
* Patients with moderate-severe/ severe Graves' eye disease

Primary outcomes:
measure: Composite score of changes
timeFrame: Change from baseline examined at 3 months follow-up.
Secondary outcomes:
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Days of sick-leave
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Days of sick-leave
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Days of sick-leave
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Days of sick-leave
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Mental fatigue score
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Mental fatigue score
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Mental fatigue score
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Mental fatigue score
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Personality Assessment Guardian NEO-FFI-3
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Personality Assessment Guardian NEO-FFI-3
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Personality Assessment Guardian NEO-FFI-3
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Personality Assessment Guardian NEO-FFI-3
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 6 weeks follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 15 months follow-up.
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 3 months follow-up
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 6 months follow-up
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 15 months follow-up
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 3 months follow-up
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 6 months follow-up
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 15 months follow-up
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 3 months follow-up
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 6 months follow-up
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 15 months follow-up
measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline examined at 3 months follow-up
measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline examined at 6 months follow-up
measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline examined at 15 months follow-up
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 3 months follow-up
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 6 months follow-up
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 15 months follow-up
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 3 months follow-up
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 6 months follow-up
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 15 months follow-up
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 3 months follow-up
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 6 months follow-up
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 15 months follow-up
measure: Severity score
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Severity score
timeFrame: Change from baseline examined at 3 months follow-up
measure: Severity score
timeFrame: Change from baseline examined at 6 months follow-up
measure: Severity score
timeFrame: Change from baseline examined at 15 months follow-up
measure: Saltin-Grimby Physical Activity Scale (SGPAS)
timeFrame: Change from baseline examined at 6 weeks follow-up
measure: Saltin-Grimby Physical Activity Scale (SGPAS)
timeFrame: Change from baseline examined at 3 months follow-up
measure: Saltin-Grimby Physical Activity Scale (SGPAS)
timeFrame: Change from baseline examined at 6 months follow-up
measure: Saltin-Grimby Physical Activity Scale (SGPAS)
timeFrame: Change from baseline examined at 15 months follow-up
measure: Composite score of changes
timeFrame: Change from 6weeks examined at 3 months follow-up.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Agneta Lindo
Study officials:
affiliation: Sahlgrenska Universitet sjukhus
name: Helena Filipsson Nyström
role: PRINCIPAL_INVESTIGATOR
References: