TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS) (TakeCharge)
Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98195
- University of Washington
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Must be diagnosed with MS by a physician.
- Must be at least 18 years of age.
- Must be able to understand, speak, and read English.
- Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
Exclusion Criteria:
- Unable to understand or read English.
- Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- Currently participating in regularly scheduled psychotherapy.
- Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
|
Brief counseling technique, self-management,
|
|
Aktiv komparator: Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
|
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
PHQ 9
Tidsram: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
|
Brief Pain Inventory
Tidsram: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
|
Modified Fatigue Impact Scale
Tidsram: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
PROMIS Depression Short Form
Tidsram: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
|
PROMIS Pain Impact Short Form
Tidsram: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
|
PROMIS Fatigue Short Form
Tidsram: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dawn Ehde, PhD, University of Washington
- Studierektor: George Kraft, MD, University of Washington
Publikationer och användbara länkar
Allmänna publikationer
- Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
- Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
- Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 36021-C
- H133B080025 (Annat bidrag/finansieringsnummer: NIDRR)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .