Myotonic dystrophy type 1
Conditions
Interventions
Patients and caregivers receive from interventional staffs the support program sessions (approximately 10 sessions) which each lasts for an hour, with a frequency of once a week to once a month.
Sponsors
National Center of Neurology and Psychiatry
National Hospital Organization, Aomori Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients and caregivers who are able to fully understand the contents of the informed consent document and from whom written consent is obtained before participation. 2) Both patient and caregiver agree to participate in the study. 3) Patients and caregivers aged 18 or older at the time of informed consent. 4) Patients who are diagnosed with DM1 by genetic testing (DMPK gene). 5) Patients who are able to move independently by walking or using an assistive device/wheelchair. 6) A caregiver is defined as "a family member, relative, partner, or friend who lives with the patient, who is not in a caregiving profession, and who reduces the patient's burden due to illness regardless of the level of care provided".
Exclusion criteria
Exclusion criteria: 1) If either the patient or caregiver is unwilling to participate in the study. 2) If patient has intake of antipsychotics and/or mood stabilizers. 3) If there was a change in dosage of antidepressants, anti-anxiety drugs, sleeping pills, Modafinil, and Ritalin in the past 12 months. However, intake of as-needed anxiolytics and sleeping pills are allowed. 4) If the caregiver is in caregiving profession. 5) Other cases in which the principal investigator or research co-investigator determines that the participant is not suitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Activity and Participation: Frenchay Activities Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue: Fatigue Severity Scale Daytime Sleepiness: Epworth Sleepiness Scale QOL: SF-12v2 Apathy: Apathy Evaluation Scale Caregiver version Cognitive ability: Mini Mental State Examination Caregiving burden: Zarit Caregiver Burden Short version | — |
Countries
Japan
Contacts
Public ContactMakiko Endo
National Center of Neurology and Psychiatry Hospital, Clinical Research Unit
Outcome results
None listed