Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309316
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-03-06
Brief Title:
The Impact of Person Centred Care PCC in Graves Disease
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
The Impact of Person Centred Care PCC on Mental Outcome and Work Ability in Graves Disease - the GRAves CarE GRACE PCC Project
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None