Scleroderma, SystemicSScM398-1NCT03766243
A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis
A study testing Brochure and DVD plus nursing training and Brochure and DVD only in people with Scleroderma, Systemic, run by IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Brochure and DVD plus nursing training and Brochure and DVD only
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 31 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scleroderma, Systemic
- Being tested
- Brochure and DVD plus nursing training, Brochure and DVD only
- Keywords
- Microstomia, Rehabilitation, Self-Management
- Medical subject headings
- Scleroderma, Systemic, Microstomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brochure and DVD plus nursing trainingBehavioural
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.
Brochure and DVD onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brochure and DVD plus nursing training | Experimental | 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. Receives: Behavioral: Brochure and DVD plus nursing training |
| Brochure and DVD only | Active comparator | 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. Receives: Behavioral: Brochure and DVD only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interincisal distance
Change in the maximum distance between the tip of the upper and lower incisors, from baseline to 1-year follow-up.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Feb 2013
- Primary completion31 Jan 2015
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
- Sponsor type
- University, hospital or other
- Collaborators
- Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI), Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Damiano DC Abeni, MD, MPH, Study chair, IDI-IRCCS, Fondazione Luigi Maria Monti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766243
- Sponsor's protocol ID
- SScMicrostomia398-1
- Acronym
- SScM398-1
- Status last verified
- Dec 2018
- First submitted
- 19 Jul 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 6587299Ayala 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.
PubMed 20072058Maddali 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.
PubMed 21847653Uras 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.
PubMed 25969348Synnot 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.
PubMed 24809816Kroon 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;2014(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.
PubMed 24425500Lorig 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.
PubMed 11897275
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03766243
- Acronym / sponsor ID
- SScM398-1 / SScMicrostomia398-1
- Conditions
- Scleroderma, Systemic
- Keywords
- Microstomia, Rehabilitation, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria MontiUniversity, hospital or other
- Collaborators
- Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI), Ministry of Health, Italy
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brochure and DVD plus nursing training | Experimental | Behavioral: Brochure and DVD plus nursing trainingIn 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. |
| Brochure and DVD only | Active comparator | Behavioral: Brochure and DVD onlyAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- edentulous patients,
- presence of dental conditions,
- documented dysfunction of the temporo-mandibular joint,
- oral neoplasia,
- sub-mandibular inflammatory conditions,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brochure and DVD plus nursing trainingAfter 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. | Behavioural | Brochure and DVD plus nursing training |
| Brochure and DVD onlyAfter 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. | Behavioural | Brochure and DVD only |
Primary outcome
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.
4 secondary outcomes
Self-reported severity of mouth disability
Time frame: 1 year
Dermatological life quality
Time frame: 1 year
Disease-specific life quality
Time frame: 1 year
Psychological well-being
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Background: PubMed 6587299Naylor 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.
- Background: PubMed 20072058Ayala 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.
- Background: PubMed 21847653Maddali 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.
- Background: PubMed 25969348Uras 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.
- Background: PubMed 24809816Synnot 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.
- Background: PubMed 24425500Kroon 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;2014(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.
- Background: PubMed 11897275Lorig 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damiano DC Abeni, MD, MPH study chair
IDI-IRCCS, Fondazione Luigi Maria Monti
Questions about this trial
What is this clinical trial studying?
A study testing Brochure and DVD plus nursing training and Brochure and DVD only in people with Scleroderma, Systemic, run by IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interincisal distance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766243, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.