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Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring fibromyalgia, nurse, nursing, medical cannabis, education, interview

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Medicine, University of Milano-Bicocca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Educational intervention

Arm Description

a Skype-videoconference, which included a 30 min educational intervention, was held with each subject.

Outcomes

Primary Outcome Measures

Subjective improvement assessed with Fibromyalgia Impact Questionnaire Revised (FIQR) questionnaire
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)
Subjective improvement assessed with the A-14 Scale
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)
Subjective improvement assessed with the Clinical Global Impression - Global Improvement (CGI-I) Scale
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

Secondary Outcome Measures

Full Information

First Posted
January 27, 2022
Last Updated
February 9, 2022
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT05247411
Brief Title
Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients
Official Title
Nurse Educational Intervention Improves Symptoms Control and Compliance in Fibromyalgia Patients on Medical Cannabis Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milano Bicocca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, nurse, nursing, medical cannabis, education, interview

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
a Skype-videoconference, which included a 30 min educational intervention, was held with each subject.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
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 Outcome Measure Information:
Title
Subjective improvement assessed with Fibromyalgia Impact Questionnaire Revised (FIQR) questionnaire
Description
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)
Time Frame
baseline and 14 days
Title
Subjective improvement assessed with the A-14 Scale
Description
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)
Time Frame
baseline and 14 days
Title
Subjective improvement assessed with the Clinical Global Impression - Global Improvement (CGI-I) Scale
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
School of Medicine, University of Milano-Bicocca
City
Monza
ZIP/Postal Code
20900
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20526405
Citation
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
Results Reference
result
PubMed Identifier
19664287
Citation
Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10. Erratum In: Arthritis Res Ther. 2009;11(5):415.
Results Reference
result
PubMed Identifier
19381860
Citation
Jank S, Bertsche T, Schellberg D, Herzog W, Haefeli WE. The A14-scale: development and evaluation of a questionnaire for assessment of adherence and individual barriers. Pharm World Sci. 2009 Aug;31(4):426-431. doi: 10.1007/s11096-009-9296-x. Epub 2009 Apr 21.
Results Reference
result
PubMed Identifier
17872937
Citation
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
Results Reference
result

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Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients

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