The Impact of Person Centred Care (PCC) in Grave's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Person-centred care (PCC).
- Who it may be relevant to
- Registry conditions: Graves Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project
Overview
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.
Interventions
- Behavioral Person-centred care (PCC)
In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. Primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the intervention will continue for the period of care 12-18 months, increasing transferability to regular care.
Primary outcome measures
- Composite score of changes [Time frame: Change from baseline examined at 3 months follow-up.]
Secondary outcome measures (12)
- General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 6 weeks follow-up.]
- General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 3 months follow-up.]
- General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 6 months follow-up.]
- General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 15 months follow-up.]
- Days of sick-leave [Time frame: Change from baseline examined at 6 weeks follow-up.]
- Days of sick-leave [Time frame: Change from baseline examined at 3 months follow-up.]
- Days of sick-leave [Time frame: Change from baseline examined at 6 months follow-up.]
- Days of sick-leave [Time frame: Change from baseline examined at 15 months follow-up.]
- Mental fatigue score [Time frame: Change from baseline examined at 6 weeks follow-up.]
- Mental fatigue score [Time frame: Change from baseline examined at 3 months follow-up.]
- Mental fatigue score [Time frame: Change from baseline examined at 6 months follow-up.]
- Mental fatigue score [Time frame: Change from baseline examined at 15 months follow-up.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Sweden · 1 center
- Agneta Lindo — Gothenburg
Identifiers
NCT: NCT06309316 · Grace-PCC