Nurse Educational Intervention to Improve Symptoms in Fibromyalgia Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedFebruary 18, 2022
February 1, 2022
8 months
January 27, 2022
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
baseline and 14 days
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)
baseline and 14 days
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
14 days
Study Arms (1)
Educational intervention
EXPERIMENTALa Skype-videoconference, which included a 30 min educational intervention, was held with each subject.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- patients not in Medical Cannabis therapy and/or not interested in starting the therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Medicine, University of Milano-Bicocca
Monza, 20900, Italy
Related Publications (4)
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PMID: 20526405RESULTBennett 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.
PMID: 19664287RESULTJank 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.
PMID: 19381860RESULTTong 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.
PMID: 17872937RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 18, 2022
Study Start
July 15, 2020
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
February 18, 2022
Record last verified: 2022-02