The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Composite score of changes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Composite score of changes
Time Frame: Change from baseline examined at 3 months follow-up.
A patient is classified as improved, deteriorated or unchanged: A patient is classified as improved if: at 3 months increased general self-efficacy by ≥ 5 units and reduced sick leave percentage (or unchanged if no sick-leave at baseline) at 3 months follow-up A patient is classified as deteriorated if: at 3 months reduced general self-efficacy by ≥ 5 units or increased sick-leave percentage (or unchanged if on full-time sick leave at inclusion) Those who have neither improved or deteriorated are classified as unchanged
Secondary Outcomes
- Perceived Stress Scale (PSS-14)(Change from baseline examined at 15 months follow-up.)
- Severity score(Change from baseline examined at 15 months follow-up)
- Saltin-Grimby Physical Activity Scale (SGPAS)(Change from baseline examined at 15 months follow-up)
- General Self-Efficacy Scale (GSE)(Change from baseline examined at 15 months follow-up.)
- Days of sick-leave(Change from baseline examined at 15 months follow-up.)
- Mental fatigue score(Change from baseline examined at 15 months follow-up.)
- Coping Orientations to Problems Experienced (Brief cope)(Change from baseline examined at 15 months follow-up.)
- Personality Assessment Guardian NEO-FFI-3(Change from baseline examined at 15 months follow-up.)
- Comprehensive psychopathological rating questionnaire (CPRS)(Change from baseline examined at 15 months follow-up.)
- Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)(Change from baseline examined at 15 months follow-up.)
- Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).(Change from baseline examined at 15 months follow-up)
- Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)(Change from baseline examined at 15 months follow-up)
- Composite score of changes(Change from 6weeks examined at 3 months follow-up.)
- EuroQol- health questionnaire (EQ-5D)(Change from baseline examined at 15 months follow-up)
- Frenchay Activities Index (FAI)(Change from baseline examined at 15 months follow-up)
- Levels of thyroid hormones(Change from baseline examined at 15 months follow-up)
- Levels of thyroid autoantibodies(Change from baseline examined at 15 months follow-up)
- Clinical Activity Score (CAS)(Change from baseline examined at 15 months follow-up)