Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04909606

Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy

Long term corticosteroid therapy concerns 0.5 to 1% of the population and about 2.5% of elderly subjects. It is currently used as a cornerstone therapy in a wide variety of clinical contexts. The central problematic of prolonged corticosteroid therapy is the burden of adverse events associated with its long term use, including bone, metabolic and infectious complications.

The management of patients for whom the prescription of long term corticosteroid therapy is indicated should include an evaluation of the individual risk and implementation of the appropriate preventive measures. Such an approach should particularly include cortisonic osteoporosis prevention, infectious prevention including vaccination, prevention of adrenal insufficiency, promotion of physical activity, as well as dietary management.

In France, nurse-led prevention programs are highly developed for patients initiating immunosuppressive targeted therapies. Conversely, there are no dedicated nurse-led programs for patients starting prolonged corticosteroid therapy, for several historical and economical reasons.

The implementation of such programs is likely to be beneficial at different levels, including the reduction of the number of adverse events and improvement of health-related quality of life.

The main objective of the study is to determine the long-term benefit of a nurse-led prevention program among patients starting long-term corticosteroids therapy, compared to routine care.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Long Term Corticosteroid Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brest, Brest, France

Loading trial locations.

About this study

It is a PROBE (Prospective Randomized Open trial with a Blind Evaluation) study, in which the primary endpoint will be assessed at week-52 by an independent physician blinded to the participant's allocation group.

The target population is adult patients initiating a first sequence of long term corticosteroid therapy, to the exception of onco-hematological indications, severe chronic renal failure and organ transplant.

Patients in both groups will have baseline and week-52 standardized visits including clinical evaluation, routine biology, dual-energy X-ray absorptiometry and quality of life assessment (SF-36). Corticosteroid consumption will be collected throughout the study using a dedicated notebook. At the week-52 visit, the burden of adverse events related to the use of corticosteroids will be assessed through the glucocorticoid toxicity index (GTI), completed by the blinded physician.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 or older
  • Initiation of corticosteroids within 30 days prior to inclusion
  • Estimated cumulative dosage of corticosteroids ≥ 2000 mg
  • Affiliated member of the social security system

Exclusion criteria

  • Patients unable to give consent or unable to understand the protocol
  • A patient who is not 'or is no longer' able to communicate remotely by telephone could not 'or no longer' be included in the study.
  • Patients under guardianship
  • Previous exposure to long-term corticosteroids
  • Prescription of corticosteroids for the management of malignant neoplasms
  • Severe chronic renal failure with clearance of creatinine < 30 ml/min.
  • History of organ transplantation
  • Pregnant or breastfeeding women

Treatment and study plan

nurse-led prevention program

Other

Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)

The nurse-led prevention program will include:

  • A video explaining corticosteroids related adverse events and adequate preventive measures
  • An individual interview with the trained nurse
  • A consultation with a dietetician
  • An individual sheet summarizing appropriate non-pharmacological preventive measures for the participant
  • An individual sheet summarizing appropriate pharmacological preventive measures for the referent physician
  • Phone calls at week-12, week-24 and week-36 to ensure the appropriate implementation of preventive measures

Current care

Other

Subjects randomized to the standard of care group will receive a general summary sheet of preventive measures associated with long term corticosteroids therapy (no individual assessment) in addition to the usual care provided by their physician

Primary outcomes

  1. Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy

    Time frame: 12 months

    Glucocorticoid Toxicity Index Raw Score

Secondary outcomes

  1. occurrence of at least one clinically significant complication of steroid therapy

    Time frame: 12 months

    binary criterion derived from the glucocorticoid toxicity index.

  2. Following of the quality of life

    Time frame: 12 months

    The Short Form 36 (SF36) is used to evaluate the quality of life.

  3. The occurrence of different categories of complications of long-term corticosteroid therapy

    Time frame: 12 months

    Complication categories defined by the glucocorticoid toxicity index

  4. Application of preventive drug measures

    Time frame: 12 months

    Immunization record

  5. Cumulative glucocorticoid dosage actually received

    Time frame: 12 months

    Cumulative dosage estimated at week 52 using a compliance logbook completed by the patient

Study contacts

Contact information is provided by the study sponsor or research team.

Dewi GELLEC, PH

CONTACT

[email protected]

Solen NICOL

CONTACT

[email protected]

+33298145015

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: COCORTICO

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2021
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.