NCT06309316 The Impact of Person Centred Care (PCC) in Grave's Disease
| NCT ID | NCT06309316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Graves Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2029-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2024-03-25 with a primary completion date of 2029-02-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Helena Filipsson Nyström
PRINCIPAL INVESTIGATOR
Sahlgrenska Universitet sjukhus
Frequently Asked Questions
Who can join the NCT06309316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06309316 currently recruiting?
Yes, NCT06309316 is actively recruiting participants. Contact the research team at agneta.lindo@vgregion.se for enrollment information.
Where is the NCT06309316 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06309316 clinical trial?
NCT06309316 is sponsored by Vastra Gotaland Region. The principal investigator is Helena Filipsson Nyström at Sahlgrenska Universitet sjukhus. The trial plans to enroll 220 participants.