The Impact of Person Centred Care (PCC) in Grave's Disease

NCT ID: NCT06309316

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2030-01-30

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.

Conditions

Graves Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Person-centred care (PCC)

Intervention PCC:

In addition to usual care, patients will receive PCC through physical visits, telephone and through a web-based platform for 15-months. The primary outcome is after 3 month (we expect the need of support is largest in the beginning) but the the intervention will continue for the period of care 12-18 months, increasing transferability to regular care.

Usual care:

Patients with GD have regular meetings with the endocrinologist during the treatment with anti-thyroid drugs and leave blod sampels. Many patients are on sick leave in the beginning of treatment. If questions occur between meetings, patients contact a service centre and get feed-back from the nurse or physician on duty at Sahlgrenska University Hospital in Gothenburg.

Group Type: EXPERIMENTAL

Person-centred care (PCC)

Intervention Type: BEHAVIORAL

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.

Usual care

Usual care:

Patients with GD have regular meetings with the endocrinologist during the treatment with anti-thyroid drugs and leave blod sampels. Many patients are on sick leave in the beginning of treatment. If questions occur between meetings, patients contact a service centre and get feed-back from the nurse or physician on duty at Sahlgrenska University Hospital in Gothenburg.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Filipsson Nyström

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Universitet sjukhus

Locations

Agneta Lindo

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Agneta Lindo

Role: CONTACT

agneta.lindo@vgregion.se

+46766185481

Helena Filipsson Nyström

Role: CONTACT

helena.filipsson@medic.gu.se

0705833398

Facility Contacts

Agneta Lindo

Role: primary

agneta.lindo@vgregion.se

+4676-6185481

Other Identifiers

Grace-PCC

Identifier Type: -

Identifier Source: org_study_id