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

The Impact of Person Centred Care (PCC) on Mental Outcome and Work Ability in Graves' Disease - the GRAves CarE (GRACE) PCC Project

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.

Study Overview

• Status: Recruiting
• Conditions: Graves Disease
• Intervention / Treatment: Behavioral: Person-centred care (PCC)

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agneta Lindo; Phone Number: +46766185481; Email: agneta.lindo@vgregion.se
• Study Contact Backup: Name: Helena Filipsson Nyström; Phone Number: 0705833398; Email: helena.filipsson@medic.gu.se

Study Locations

• Sweden
  • Göteborg, Sweden, 413 45
    • Recruiting
    • Agneta Lindo
    • Contact: Agneta Lindo; Phone Number: +4676-6185481; Email: agneta.lindo@vgregion.se
    • Principal Investigator: Helena Filipsson Nyström

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 3 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 3 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 6 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 6 months follow-up.
Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 3 months follow-up.
Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 6 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 6 weeks follow-up.
General Self-Efficacy Scale (GSE)	Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Change from baseline examined at 15 months follow-up.
Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up.
Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 3 months follow-up.
Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 6 months follow-up.
Days of sick-leave	Evaluated sick leave days between the intervention and the control group.	Change from baseline examined at 15 months follow-up.
Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 6 weeks follow-up.
Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 6 months follow-up.
Mental fatigue score	Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.	Change from baseline examined at 15 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up.
Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 6 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)	Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.	Change from baseline examined at 15 months follow-up.
Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 6 weeks follow-up.
Perceived Stress Scale (PSS-14)	Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.	Change from baseline examined at 15 months follow-up.
Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 6 weeks follow-up.
Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 3 months follow-up.
Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 6 months follow-up.
Personality Assessment Guardian NEO-FFI-3	The NEO Five Factor Inventory-3 (NEO-FFI-3) is a measure of the five domains of personality: neuroticism, extraversion, openness to experience, agreeableness, and conscientiousness.	Change from baseline examined at 15 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 6 weeks follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)	Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.	Change from baseline examined at 15 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 6 weeks follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 6 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)	Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.	Change from baseline examined at 15 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 6 weeks follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 3 months follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 6 months follow-up
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).	Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.	Change from baseline examined at 15 months follow-up
EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 6 weeks follow-up
EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 3 months follow-up
EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 6 months follow-up
EuroQol- health questionnaire (EQ-5D)	Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.	Change from baseline examined at 15 months follow-up
Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 6 weeks follow-up
Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 3 months follow-up
Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 6 months follow-up
Frenchay Activities Index (FAI)	Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).	Change from baseline examined at 15 months follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 6 weeks follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 3 months follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 6 months follow-up
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)	Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.	Change from baseline examined at 15 months follow-up
Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up
Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 3 months follow-up
Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 months follow-up
Levels of thyroid autoantibodies	Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 15 months follow-up
Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 weeks follow-up
Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 3 months follow-up
Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 6 months follow-up
Levels of thyroid hormones	Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.	Change from baseline examined at 15 months follow-up
Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 6 weeks follow-up
Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 3 months follow-up
Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 6 months follow-up
Clinical Activity Score (CAS)	Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.	Change from baseline examined at 15 months follow-up
Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 6 weeks follow-up
Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 3 months follow-up
Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 6 months follow-up
Severity score	Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.	Change from baseline examined at 15 months follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 6 weeks follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 3 months follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 6 months follow-up
Saltin-Grimby Physical Activity Scale (SGPAS)	Physical activity level, 1-4 (4 highest activity level).	Change from baseline examined at 15 months follow-up
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 6weeks examined at 3 months follow-up.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Helena Filipsson Nyström, Sahlgrenska Universitet sjukhus

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: eHealth; cost-effectiveness; self-efficacy; Mental fatigue; Person Centred Care
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Graves Disease
• Other Study ID Numbers: Grace-PCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No