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Completed

NCT Number: NCT05247411

Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients

To improve self-care and therapy adherence by fibromyalgia (FM) patients through a nursing educational intervention. Historic diagnoses of subjects included terms such as "insane", "imaginary ill", "whiny"; as well, their physical conditions were underestimated by their immediate families. All subjects have problematic employment histories which consistently identified their varied employments as physically too demanding. Over time, increased physician- and societal-awareness, resulted in all subjects being diagnosed with FM; consequently, all subjects reported a strong desire to become well-informed about FM and its treatment. Although medical cannabis (MC) was an available therapy, twenty subjects reported that cannabis had never been proposed despite years of ineffective therapies. In this tudy the effects of a educational intervention by expert nurses on fibromyalgia and MC use were investigated.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, University of Milano-Bicocca

Monza, 20900, Italy

About this study

Aims This study aims to evaluate the knowledge of fibromyalgia patients who use therapeutic cannabis or are interested in taking it, introducing the figure of the nurse in the therapeutic path of patients. The primary objective was to increase the knowledge relating to FM (in terms of symptoms, onset, treatment strategies that can improve the quality of life), self-care and adherence through a nursing educational intervention. The secondary objective was to evaluate the efficacy of the nursing educational intervention, using validated clinimetric scales.

Design We performed a qualitative study with face-to-face semi-structured interviews and patient tailored educational interventions. Two weeks before the interview, subjects were asked to complete the Fibromyalgia Impact Questionnaire Revised (FIQR) and the A-14 Scale online. Two weeks after the interview, patients were asked to complete the same questionnaires in addition the Clinical Global Impression - Global Improvement (CGI-I) Scale. This study adheres to the Consolidated criteria for Reporting Qualitative research (COREQ).

Data collection After obtaining written informed consent for participation in the study, each participant was asked to complete online the Fibromyalgia Impact Questionnaire Revised (FIQR) and The A-14 Scale. Two weeks after completing these online questionnaires, a Skype-videoconference, which included a 30 min educational intervention, was held with each subject. Two weeks after the videoconference, patients were required to complete the FIQR, The A-14 Scale, as well as the Clinical Global Impression - Global Improvement (CGI-I) Scale Data analysis Descriptive analyses were performed on study participants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of fibromyalgia syndrome carried out for more than 3 months and confirmed by the specialist (rheumatologist / algologist);
  • age> 18 years;
  • ability to understand the objectives and methods of the study and to read and sign the informed consent form.

Exclusion criteria

  • patients not in Medical Cannabis therapy and/or not interested in starting the therapy

Treatment and study plan

Educational Intervention

Other

During the videoconference, the following items were investigated and evaluated:

(i) Knowledge on FM: knowledge on symptoms, onset, treatment, strategies and non-pharmacological interventions that can be implemented to improve the quality of life (physical exercise, nutrition, participation in meditative movement practices, mutual aid groups, membership in a patient association, etc.); (ii) Any MC intake or interest in starting the intake of MC; (iii) Knowledge on MC therapy: specific knowledge on the drug, correct intake, adherence, treatment of side effects related to intake and strategies to reduce them; (iv) Self-care: how the person manages his personal life despite a chronic disease, how she or he monitors, recognizes and treats the symptoms in terms of timing and quality; possible presence of caregivers in their life who help in the management of the disease; employment and how FM affects it and daily life.

Primary outcomes

  1. Subjective improvement assessed with Fibromyalgia Impact Questionnaire Revised (FIQR) questionnaire

    Time frame: baseline and 14 days

    At baseline and two weeks after the videoconference, patients were required to complete the Fibromyalgia Impact Questionnaire Revised (FIQR), in order to assess effects of the educational intervention on therapeutic perspective and compliance. The FIQR is made of 21 items and the answers range between 0 (best performance) and 10 (worst performance)

  2. Subjective improvement assessed with the A-14 Scale

    Time frame: baseline and 14 days

    At baseline and two weeks after the videoconference, patients were required to complete the A-14 Scale, in order to assess effects of the educational intervention on therapeutic perspective and compliance. The A-14 Scale is made up of 14 questions, which can be answered using a 5-element Likert-scale (from "never" [5] to "very often" [0]). The result of the scale ranges from "non-compliant" (score <50) to "compliant" (score 50-56)

  3. Subjective improvement assessed with the Clinical Global Impression - Global Improvement (CGI-I) Scale

    Time frame: 14 days

    At two weeks after the videoconference, patients were required to complete the Clinical Global Impression - Global Improvement (CGI-I) Scale, which measures the subjective progress of the patient, in order to assess effects of the educational intervention on therapeutic perspective and compliance. Scores are the followings: 1 Minimally improved: 2 Much improved; 3 Very much improved; 4 No change; 5 Minimally worse; 6 Much worse; 7 Very much worse

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

Nurse Educational Intervention Improves Symptoms Control and Compliance in Fibromyalgia Patients on Medical Cannabis Therapy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2022
Registry last updated
Feb 18, 2022

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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