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NCT Number: NCT06620770

Impact of the Therapeutic Education Program "living with a Chronic Inflammatory Disease Under Biotherapy" on Patient Compliance and Quality of Life

Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program.

This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the Lorient hospital.

The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

All patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology, rheumatology, hepatotherapygastroenterology, will be offered participation in the therapeutic education program by GHBS specialists. Whether they agree to participate or not, doctors will offer them participation in the IMPEBIO study.

Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group.

Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group. The therapeutic education program will begin within 3 months of inclusion.

If the patient does not object, the Morisky scale and the SF 12 questionnaire will be given to him. It may be assisted with filling if necessary by a clinical researcher.

Patients will first complete the Morisky test, and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study (J0), then to M6 (6 months), M12 (12 months) and M18 (18 months).

These questionnaires will then be retrieved, anonymized and sent to the investigation department. The analysis of questionnaires will not lead to changes in patient management.

Estimated time to complete the questionnaires is 10 minutes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.
  • Patients not opposed to their participation in the research.
  • Less than 3 months between inclusion and start of Therapeutic Education Program.

Exclusion criteria

  • Subcutaneous injection by another person.
  • Patients with cognitive impairment.
  • Persons of legal age who are the subject of a legal protection (safeguarding of justice, curatorship, guardianship), persons deprived of liberty.
  • Pregnant women.
  • Persons not covered by social security.

Treatment and study plan

questionnaires

Other

Morisky and SF12 Questionnaires delivery at inclusion, 6, 12 and 18 months

Primary outcomes

  1. Scores of the Morisky scale

    Time frame: 18 months after inclusion

    Comparison of the scores of the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 18 months after inclusion versus patients who only received nurse consultation.

Secondary outcomes

  1. Scores of the Morisky scale

    Time frame: 6 and 12 months after inclusion

    Comparison of scores on the Morisky scale in patients with chronic inflammatory disease treated by S/C biotherapy at 6 and 12 months after inclusion versus patients who only received nurse consultation.

  2. SF-12 quality of life questionnaire

    Time frame: 6 and 12 and 18 months after inclusion

    Comparison of the SF-12 quality of life questionnaire in patients at 6, 12 and 18 months after inclusion versus patients who only received nurse consultation.

Study contacts

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

Olivier Gall

CONTACT

[email protected]

02 97 06 79 11 ext. +33

Pierre Bouju

CONTACT

[email protected]

02 97 06 75 14 ext. +33

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de Bretagne Sud

Other

Registry information

Official study title

Impact of the Therapeutic Education Program "living with Chronic Inflammatory Disease Under Biotherapy" on Compliance and Quality of Life of Patients

Acronym: IMPEBIO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Mar 14, 2025

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.

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