myotonic dystrophy type 1
Conditions
Interventions
[Intervention Group] A psychosocial support program will be implemented. The program, entitled "
Psychosocial Self-Care Program for Patients with Myotonic Dystrophy Type 1 and Their Caregivers"
is designed to help patients and caregivers learn self-care strategies for promoting mental health and social participation together with healthcare professionals. The study will examine whether parti
Sponsors
National Center of Neurology and Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients and caregivers who are able to sufficiently understand the contents of the study information sheet and from whom written informed consent has been obtained prior to study initiation. 2. Both the patient and the caregiver have agreed to participate in the study. 3. Patients and caregivers aged 18 years or older at the time informed consent is obtained. 4. Patients diagnosed with DM1 based on genetic testing of the *DMPK* gene. 5. Patients who are able to move independently, either by walking or with the use of assistive devices and/or a wheelchair. 6. "Caregiver" refers to a family member, relative, partner, or friend who lives with the patient, or, in the case of patients with long-term hospitalization, the family member, relative, partner, or friend who is closest to the patient. The term includes any person who helps reduce the burden experienced by the patient due to the disease, regardless of the extent of caregiving provided. 7. The caregiver is aware that the patient has been diagnosed with DM1.
Exclusion criteria
Exclusion criteria: 1. Either the patient or the caregiver does not wish to participate in the study. 2. Patient and/or caregiver is taking antipsychotic medication and/or mood stabilizers. 3. Patient and/or caregiver is taking antidepressants, anxiolytics, hypnotics/sleep medications, Modafinil, or Ritalin, and the dosage has changed within the past 12 months. However, as-needed use of anxiolytics and sleep medications will not be considered exclusion criteria. 4. Caregiver is a professional caregiver. 5. Cases judged by the principal investigator or sub-investigators to be unsuitable for participation in the study for any other reason. 6. Participant is enrolled in another interventional study, clinical trial, or observational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of the Frenchay Activities Index (FAI), a measure of the level of activity and participation. Assessments will be conducted at baseline, 10 months, and 13 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| ADL / Muscular impairment * Barthel Index (baseline) * Muscular Impairment Rating Scale (MIRS) (baseline) DM1-specific symptoms * Fatigue Severity Scale (FSS) (baseline, 10 months, and 13 months) * Epworth Sleepiness Scale (ESS) (baseline, 10 months, and 13 months) * Apathy Evaluation Scale, caregiver version (AES) (baseline, 10 months, and 13 months) QOL / Patients' perceptions of their illness * SF-12v2 (baseline, 10 months, and 13 months) * Individualized Neuromuscular Quality of Life Questionnaire (INQoL) (baseline, 10 months, and 13 months) Cognitive function / Intellectual standard * Japanese Adult Reading Test (JART25) (baseline) * Mini-Mental State Examination (MMSE) (baseline, 10 months, and 13 months) Caregiver burden * Japanese version of the shortened Zarit Caregiver Burden Index (J-ZBI8) (baseline, 10 months, and 13 months) | — |
Countries
Japan
Contacts
Public ContactMakiko Endo
National Center of Neurology and Psychiatry NCNP Hospital, Department of Clinical Research Support
Outcome results
None listed