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

Vastra Gotaland Region

Status: Enrolling

Conditions: Graves Disease

Treatments: Behavioral: Person-centred care (PCC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06309316

Grace-PCC

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Person-centred care (PCC)

Experimental group

Description:

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.

Treatment:

Behavioral: Person-centred care (PCC)

Usual care

No Intervention group

Description:

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.