- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766243
A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis (SScM398-1)
A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis: a Randomized Controlled Trial
Background: A typical feature of SSc is the fibrotic involvement of the connectival tissue of the face, which causes microstomia.
Objectives: To test the effectiveness of an educational intervention with "face to face" training, compared to a standard information program, to reduce microstomia in women with SSc.
Methods: SSc patients were randomized to the experimental and control group. Both groups received written and audiovisual information for self-management of microstomia; in addition, the experimental group received a reinforced training at baseline and at follow-up. Primary outcome: change in inter-incisal distance; secondary outcome: patient-reported mouth disability.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was designed as a single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Recruitment started in February 2013 and it continued until January 2015. After recruitment, the patients were seen quarterly (i.e., follow-up visits at 3, 6, 9, and 12 months). Before follow-up visits, patients were contacted by phone to remind them of their appointment.
The participants were inpatients, mainly from Central and Southern Italy, and they were enrolled in a single center, the IDI-IRCCS, FLMM, in Rome, a large dermatological reference center.
Inclusion criteria were diagnosis of Systemic Sclerosis, according to the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria;23 age >18 years; ability to understand the Italian language; subjective perception of problems with opening the mouth, such as hardened tissues, reduced mobility, pain - confirmed by a dermatologist; signed informed consent.
Exclusion criteria were edentulous patients, presence of dental conditions, documented dysfunction of the temporo-mandibular joint, oral neoplasia, sub-mandibular inflammatory conditions, patients already undergoing face massages or face physiotherapy, patients who had undergone mouth lipofilling, patients with severe hand disability (including deep ulcers, and severe pain), and patients with documented psychiatric conditions or taking psychotropic medications.
Randomization The assignment to the intervention and control group was made according to a random sequence generated by a computer program. The randomization list was maintained by an investigator who was not involved in patient recruitment nor in outcome measurement.
Each entry of the randomization list was placed in a sealed envelope, numbered in ascending order, and given to a research nurse after the inclusion/exclusion criteria were verified and the informed consent was obtained.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of SSc, according to the ACR/EULAR criteria;
- age >18 years;
- ability to understand the Italian language;
- subjective perception of problems with opening the mouth, such as hardened tissues, reduced mobility, pain - confirmed by a dermatologist;
- signed informed consent.
Exclusion Criteria:
- edentulous patients,
- presence of dental conditions,
- documented dysfunction of the temporo-mandibular joint,
- oral neoplasia,
- sub-mandibular inflammatory conditions,
- patients already undergoing face massages or face physiotherapy,
- patients who had undergone mouth lipofilling,
- patients with severe hand disability (including deep ulcers, and severe pain),
- patients with documented psychiatric conditions or taking psychotropic medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Brochure and DVD plus nursing training
In addition to the "control intervention", see below, the experimental group was closely followed by the research nurse, an expert in Adult Education, who held 20-minute "face to face" meetings at baseline and at follow-up with the patients allocated to the experimental group.
The nurse provided theoretical explanations on the exercises, watched the explanatory DVD with the patients, answering questions and commenting relevant points, and then had the patients repeat the exercises in front of a mirror under direct observation, so that any errors could be pointed out and corrected.
|
After recruitment for both groups of participants, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use. The intervention consisted of stretching exercises and movements involving the mimic muscles to perform in front of a mirror. The control group could learn the standardized exercises for the mouth-opening through information brochure and the audio-visual DVD. The experimental group was closely followed by the research nurse, an expert in Adult Education, who held 20-minute "face to face" meetings at baseline and at follow-up with the patients allocated to the experimental group. For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The audio-visual DVD is available on the IDI-IRCCS institutional website. |
ACTIVE_COMPARATOR: Brochure and DVD only
After recruitment, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use. At the same time, she contacted the research nurse to obtain the random allocation to one of the study groups for that patient. These exercises had to be done every day for the entire duration of the program (12 months) and registered in the diary with any comments. |
After recruitment for both groups of participants, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use. The intervention consisted of stretching exercises and movements involving the mimic muscles to perform in front of a mirror. The control group could learn the standardized exercises for the mouth-opening through information brochure and the audio-visual DVD. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interincisal distance
Time Frame: 1 year
|
Change in the maximum distance between the tip of the upper and lower incisors, from baseline to 1-year follow-up.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported severity of mouth disability
Time Frame: 1 year
|
To measure mouth disability, the investigators used the Italian version of the standardized self-administered questionnaire Mouth Handicap in Systemic Sclerosis (MHISS).
MHISS consists of 12 items (each scored 0-4, with a total score ranging from 0 to 48) divided into 3 subscales: subscale 1 (5 items: 1, 3, 4, 5 and 6; range 0-20) examines handicap related to reduced mouth opening; subscale 2 (5 items: 2, 7, 8, 9 and 10; range 0-20) assesses handicap related to sicca syndrome; and subscale 3 (items 11 and 12; range 0-8) examines aesthetic concerns.
The total score is obtained by summing the score for all items.
Higher scores denote a greater mouth disability.
|
1 year
|
Dermatological life quality
Time Frame: 1 year
|
Quality of life was measured with the Skindex-17, a dermatology-specific questionnaire consisting of 17 items subdivided into two scales: Symptoms and Psychosocial.
Possible range for both scales 0 - 100.
Higher scores indicate a greater impact of the disease.
Interpretation: for the Symptoms scale, <50 non-severe, >=50 severe; for the Psychosocial scale, <20.82 mild, 20.83-37.50
moderate, >=37.51 severe.
|
1 year
|
Disease-specific life quality
Time Frame: 1 year
|
To measure disease-specific life quality the investigators used the Systemic Sclerosis Questionnaire (SySQ), a self-administered standardized questionnaire whose Italian version was validated in our institution.
The SySQ has four scales: General Symptoms, 8 items; Muscle-Skeletal, 11 items; Cardio-Respiratory, 6 items; Gastro-Intestinal, 7 items.
Items are all scored 0-3.
Scale scores are given by the mean of the items belonging to that scale, again with range 0-3.
Higher scores indicate a worse quality of life.
|
1 year
|
Psychological well-being
Time Frame: 1 year
|
Possible presence of anxiety/depression was investigated with a generic questionnaire validated in the field of dermatology, the 12-item General Health Questionnaire-12 (GHQ-12).
GHQ-12 items have 4 possible answers, and scores were computed in the conventional way, collapsing adjacent responses to obtain a dichotomous scoring (0 + 0 + 1 + 1).
Possible score 0-12.
Based on previous research, patients were classified as "GHQ-cases" (i.e., with probable minor non psychotic disorders) if the dichotomous scoring was >=4; and as "GHQ-noncases" if the dichotomous scoring was <4.
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Damiano DC Abeni, MD, MPH, IDI-IRCCS, Fondazione Luigi Maria Monti
Publications and helpful links
General Publications
- Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014 May 9;2014(5):CD003717. doi: 10.1002/14651858.CD003717.pub3.
- Naylor WP, Douglass CW, Mix E. The nonsurgical treatment of microstomia in scleroderma: a pilot study. Oral Surg Oral Med Oral Pathol. 1984 May;57(5):508-11. doi: 10.1016/0030-4220(84)90309-8.
- Ayala F, de Baranda Andujar PS. Effect of 3 different active stretch durations on hip flexion range of motion. J Strength Cond Res. 2010 Feb;24(2):430-6. doi: 10.1519/JSC.0b013e3181c0674f.
- Maddali Bongi S, Del Rosso A, Miniati I, Galluccio F, Landi G, Tai G, Matucci-Cerinic M. The Italian version of the Mouth Handicap in Systemic Sclerosis scale (MHISS) is valid, reliable and useful in assessing oral health-related quality of life (OHRQoL) in systemic sclerosis (SSc) patients. Rheumatol Int. 2012 Sep;32(9):2785-90. doi: 10.1007/s00296-011-2049-x. Epub 2011 Aug 17.
- Uras C, Giannantoni P, Tabolli S, DI Giulio P, Peghetti A, Cianchini G, Abeni D. Measuring disability of women with systemic sclerosis: validation of the italian version of the systemic sclerosis questionnaire. G Ital Dermatol Venereol. 2016 Aug;151(4):332-9. Epub 2015 May 13.
- Kroon FP, van der Burg LR, Buchbinder R, Osborne RH, Johnston RV, Pitt V. Self-management education programmes for osteoarthritis. Cochrane Database Syst Rev. 2014 Jan 15;(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.
- Lorig K. Partnerships between expert patients and physicians. Lancet. 2002 Mar 9;359(9309):814-5. doi: 10.1016/S0140-6736(02)07959-X. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SScMicrostomia398-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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