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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98195
- University of Washington
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
|
Brief counseling technique, self-management,
|
|
アクティブコンパレータ：Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
|
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
PHQ 9
時間枠：Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
|
Brief Pain Inventory
時間枠：Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
|
Modified Fatigue Impact Scale
時間枠：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
PROMIS Depression Short Form
時間枠：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
|
PROMIS Pain Impact Short Form
時間枠：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
|
PROMIS Fatigue Short Form
時間枠：Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Dawn Ehde, PhD、University of Washington
- スタディディレクター：George Kraft, MD、University of Washington
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。