All studies
RecruitingNAINTERVENTIONAL

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

Taking corticosteroids for a long time can lead to health problems like weak bones, infections, and issues with metabolism. This study wants to see if a special program, led by nurses, can help people avoid these problems. Many people, especially older people, take these medicines, and there isn't currently a dedicated nurse program in France, where this study is based, to help manage the side effects. The study will compare patients receiving this new nurse-led program with those receiving standard care. The main goal is to find out if the program improves long-term health and reduces unwanted side effects for adults starting long-term corticosteroid treatment.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Brest
Enrolment target
191
Start
26 Apr 2022
Estimated completion
26 Oct 2028

What is this study about?

This study is looking into how we can improve the care for people who need to take corticosteroid medicines for a long time. Corticosteroids are widely used for many different health conditions, but when taken over a long period, they can sometimes cause unwanted side effects like brittle bones, infections, or problems with your body's systems. This can affect a person's overall health and quality of life.

Currently, when someone starts long-term corticosteroids, their doctors usually consider ways to prevent these problems. This might include advice on bone strength, vaccinations, what to eat, and staying active. However, there isn't a specific nurse-led program designed to help manage these risks from the start.

This study aims to find out if a dedicated nurse-led program, where nurses guide patients through preventive measures, can make a real difference. Researchers believe such a program could lead to fewer side effects and a better quality of life for patients. They will be comparing this new nurse-led approach with the standard care that patients usually receive, to see which approach works best over time.

Key takeaways

  • This study evaluates a nurse-led program for people on long-term corticosteroids.
  • It aims to prevent side effects like bone problems and infections.
  • The program is compared to standard care to see which is more effective.
  • Participation involves health checks, blood tests, and quality of life assessments over one year.
  • The goal is improved health and fewer complications for patients.

Who may be eligible?

To join this study, people must be 18 years old or older and just starting a long course of corticosteroid treatment – specifically, within the last 30 days. You would also need to be a member of the social security system in France, where the study is taking place. The total amount of corticosteroids you're expected to take needs to be at least 2000mg over time.

There are also some reasons why you wouldn't be able to join. For example, if you've taken long-term corticosteroids before, or if you're taking them for cancer treatment. If you have severe kidney problems, have had an organ transplant, or if you are pregnant or breastfeeding, you also wouldn't be eligible. It's also important to be able to talk on the phone and understand what the study involves, so people who struggle with this or are under guardianship cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you started long-term corticosteroid treatment within the last 30 days?
  3. Have you NOT taken long-term corticosteroids before?
  4. Are you NOT pregnant or breastfeeding?
  5. Are you NOT taking corticosteroids for cancer treatment?
  6. Do you NOT have severe kidney failure or have had an organ transplant?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either receive the new nurse-led prevention program or continue with your usual care. You'll have regular visits at the start of the study and again after 52 weeks (about a year). During these visits, doctors will check your general health, do some blood tests, and measure your bone density with a special scan called a DEXA scan. You'll also be asked to fill out questionnaires to assess your quality of life.

You'll be asked to keep a record of how much corticosteroid medicine you take throughout the year. At your final visit after 52 weeks, an independent doctor, who won't know whether you were in the nurse-led program or the usual care group, will assess any side effects you might have experienced from the corticosteroids. The total duration of your participation in the assessments will be one year.

Potential risks and benefits

The main benefit of taking part in this study could be that you receive additional support and guidance through the nurse-led program to help prevent side effects from your corticosteroid treatment. This could lead to better health outcomes and a better quality of life. As with any study, there's always a chance you might not experience a direct benefit, especially if you are in the usual care group. There are no direct physical risks from the study interventions themselves, beyond what is already part of your medical care and the measurements like blood tests or DEXA scans. You are free to withdraw from the study at any time without affecting your medical treatment.

Locations (5)

  • CHU Brest
    Verified postcode
    Brest, France· Recruiting
  • CH La Rochelle
    Verified postcode
    La Rochelle, France· Recruiting
  • CH Le Mans
    Verified postcode
    Le Mans, France· Enrolling by invitation
  • CH Le Puy en Velay
    Verified postcode
    Le Puy-en-Velay, France· Recruiting
  • CH de Morlaix
    Verified postcode
    Morlaix, France· Enrolling by invitation

Common questions

What are corticosteroids?

Corticosteroids are medicines used to reduce inflammation and suppress the immune system for various health conditions.

Why is long-term use a concern?

Taking them for a long time can lead to side effects like weak bones, infections, and other health issues.

What is a nurse-led program?

It's a special program where nurses provide guidance and support to help prevent common side effects of long-term corticosteroid use.

Will I still get my usual medical care?

Yes, all participants will continue to receive the standard medical care for their condition.

How long does the study last?

Your involvement in the study, including assessments, will last for about one year.

How to find out more

Solen NICOL

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of a Nurse-led Program for the Prevention of Comp…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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