Self-management in Patients With Adrenal Insufficiency.

October 10, 2024 updated by: Region Stockholm

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

Adrenal insufficiency or relative to a person with adrenal insufficiency

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with adrenal insufficiency and their relatives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 6 months
Rate of participants responding accurately regarding stree-dosing in hypothetical situation of different degrees of physical and psychological stress.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

August 1, 2020

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K0000-9980

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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