NCT06637722

Brief Summary

Background: Cortisol deficiency leads to a wide range of clinical consequences. Substitution with glucocorticoids is necessary and demands knowledge and ability to self-management from the patient. Methods: Longitudinal questionnaire-based observational study including group education. Research questions: To find out if education in group, enhances patients´ and relatives' knowledge about adequate dose adjustment of cortisone and increases the feeling of safety and QoL in patients with adrenal insufficiency.

Trial Health

53
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

September 1, 2024

Enrollment Period

4.9 years

First QC Date

October 2, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

Adrenal insufficiencyself-management

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    Rate of participants responding accurately regarding stree-dosing in hypothetical situation of different degrees of physical and psychological stress.

    6 months

Study Arms (1)

Patients with adrenal insufficiency and their relatives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with adrenal insufficiency cared for at at the endocrinology department at Karolinska university hospital, Örebro university hospital, university hospital linköping or university hospital of Umeå and their relatives.

You may qualify if:

  • Adrenal insufficiency or relative to a person with adrenal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 15, 2024

Study Start

September 1, 2015

Primary Completion

August 1, 2020

Study Completion

March 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share