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A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis (SScM398-1)

Primary Purpose

Scleroderma, Systemic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brochure and DVD plus nursing training
Brochure and DVD only
Sponsored by
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Scleroderma, Systemic focused on measuring Microstomia, Rehabilitation, Self-Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Brochure and DVD plus nursing training

    Brochure and DVD only

    Arm Description

    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, 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.

    Outcomes

    Primary Outcome Measures

    Interincisal distance
    Change in the maximum distance between the tip of the upper and lower incisors, from baseline to 1-year follow-up.

    Secondary Outcome Measures

    Self-reported severity of mouth disability
    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.
    Dermatological life quality
    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.
    Disease-specific life quality
    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.
    Psychological well-being
    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.

    Full Information

    First Posted
    July 19, 2018
    Last Updated
    December 4, 2018
    Sponsor
    IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
    Collaborators
    Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI), Ministry of Health, Italy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03766243
    Brief Title
    A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis
    Acronym
    SScM398-1
    Official Title
    A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2013 (Actual)
    Primary Completion Date
    January 31, 2015 (Actual)
    Study Completion Date
    January 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
    Collaborators
    Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI), Ministry of Health, Italy

    4. Oversight

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

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scleroderma, Systemic
    Keywords
    Microstomia, Rehabilitation, Self-Management

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brochure and DVD plus nursing training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Brochure and DVD only
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brochure and DVD plus nursing training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brochure and DVD only
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Interincisal distance
    Description
    Change in the maximum distance between the tip of the upper and lower incisors, from baseline to 1-year follow-up.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Self-reported severity of mouth disability
    Description
    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.
    Time Frame
    1 year
    Title
    Dermatological life quality
    Description
    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.
    Time Frame
    1 year
    Title
    Disease-specific life quality
    Description
    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.
    Time Frame
    1 year
    Title
    Psychological well-being
    Description
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damiano DC Abeni, MD, MPH
    Organizational Affiliation
    IDI-IRCCS, Fondazione Luigi Maria Monti
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    6587299
    Citation
    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.
    Results Reference
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    PubMed Identifier
    20072058
    Citation
    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.
    Results Reference
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    PubMed Identifier
    21847653
    Citation
    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.
    Results Reference
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    PubMed Identifier
    25969348
    Citation
    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.
    Results Reference
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    PubMed Identifier
    24809816
    Citation
    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.
    Results Reference
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    Citation
    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.
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    Citation
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    A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis

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