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

NCT06309316 | Recruiting

• 1 other identifier: Grace-PCC
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

Person Centred Care; Mental fatigue; cost-effectiveness; self-efficacy; eHealth

Outcome Measures

Primary Outcomes (1)

• Composite score of changes

  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

  Change from baseline examined at 3 months follow-up.

Secondary Outcomes (69)

• General Self-Efficacy Scale (GSE)

  Change from baseline examined at 6 weeks follow-up.

• General Self-Efficacy Scale (GSE)

  Change from baseline examined at 3 months follow-up.

• General Self-Efficacy Scale (GSE)

  Change from baseline examined at 6 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 6 weeks follow-up.

Study Arms (2)

Person-centred care (PCC)

EXPERIMENTAL

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.

Behavioral: Person-centred care (PCC)

Usual care

NO INTERVENTION

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.

Interventions

Person-centred care (PCC) 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.

Person-centred care (PCC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• First time Graves' diseases with elevated FT4 and/or FT3 and positive TSH receptor antibody (TRAb)

You may not qualify if:

• Patients that cannot attend to the protocol
• Patients with moderate-severe/ severe Graves' eye disease

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Agneta Lindo

Gothenburg, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Graves Disease; Mental Fatigue

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Helena Filipsson Nyström

  Sahlgrenska Universitet sjukhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agneta Lindo

CONTACT

+46766185481; agneta.lindo@vgregion.se

Helena Filipsson Nyström

CONTACT

0705833398; helena.filipsson@medic.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): February 25, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

SE (1)