Strength and Pain-Coping Through Resilience and Knowledge

Обзор

Older adults who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the SPARK intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.

Подробное описание

SPARK (Strength and Pain-Coping through Resilience and Knowledge) is a home-based, nurse-delivered behavioral intervention designed to reduce pain interference and depressive symptoms among community-dwelling older adults with mobility limitations. Chronic pain and depression occurs together later in life and can impair daily function, independence, and overall well-being. Pain interference, how pain affects daily life, is a critical and actionable outcome that is closely linked to depressive symptoms. SPARK integrates evidence-informed strategies delivered through the Neighborhood Nursing model and brings the necessary care directly to the homes of the participants. The intervention comprises eight weekly individualized 1:1 nurse home visits that integrate goal-directed care planning, education on pain and mood self-management, and coordination with Neighborhood Nursing and Community Health workers to address barriers and leverage local resources.

Вмешательства

• Поведенческое SPARK
  The SPARK program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offe

Первичные конечные точки

• Change in Pain Intensity as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS) [Срок оценки: Baseline, 12 weeks and 24 weeks]
• Change in Pain Interference as assessed by the PROMIS Pain Interference [Срок оценки: Baseline, 12 weeks and 24 weeks]
• Change in Depressive Symptoms as assessed by the Patient Health Questionnaire 9 (PHQ-9) [Срок оценки: Baseline, 12 weeks and 24 weeks]
• Change in Depressive Symptoms as assessed by the PROMIS 57 [Срок оценки: Baseline, 12 weeks and 24 weeks]

Вторичные конечные точки (2)

• Change in Physical Function as assessed by the Katz Activities of daily living (ADL) [Срок оценки: Baseline, 12 weeks and 24 weeks]
• Change in Physical Function as assessed by the Lawton's Instrumental Activities of Daily Living (IADL) [Срок оценки: Baseline, 12 weeks and 24 weeks]

Критерии участия

Критерии включения

• Self-report pain >3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
• Live in the community
• Live in Central Maryland
• Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
• Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
• One ADL or IADL limitation

Критерии исключения

• Hospitalized > 3 times in the last year
• Participating in physical therapy
• Have a terminal diagnosis (<1 year expected survival)
• > moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
• Unable to speak or understand English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins School of Nursing — Baltimore

Публикации

• Taylor JL, Clair CA, Lee JW, Atkins S, Riser TJ, Szanton SL, McCoy MC, Thorpe RJ Jr, Wang C, Gitlin LN. A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older African American women. Contemp Clin Trials. 2023 Sep;132:107299. doi: 10.1016/j.cct.2023.107299. Epub 2023 Jul 20. PMID 37478967
• Taylor JL, Clair CA, Gitlin LN, Atkins S, Bandeen-Roche K, Abshire Saylor M, Hladek MD, Riser TJ, Thorpe RJ Jr, Szanton SL. Acceptability and Feasibility of a Pain and Depressive Symptoms Management Intervention in Middle-Aged and Older African American Women. Innov Aging. 2023 Sep 8;7(10):igad096. doi: 10.1093/geroni/igad096. eCollection 2023. PMID 38094930

Идентификаторы

NCT: NCT07228520 · IRB00529967

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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