Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study.
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| Název: | Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study. |
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| Autoři: | Vonderheide C; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., Kilduff C; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., McDermott KA; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA., Greenberg J; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA., La Camera DE; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., Giraldo-Santiago N; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA., Kurkul A; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., Alvarez-Frank N; Frances L. Hiatt School of Psychology, Clark University, Worcester, MA, USA., Kim Y; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA., Pasinski R; Massachusetts General Hospital Revere HealthCare Center, Revere, MA, USA., Gholston M; Massachusetts General Hospital Revere HealthCare Center, Revere, MA, USA., Ritchie CS; Harvard Medical School, Boston, MA, USA; Center for Aging and Serious Illness, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA., Vranceanu AM; Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: avranceanu@mgh.harvard.edu. |
| Korporace: | iHOPE Study Team |
| Zdroj: | Contemporary clinical trials [Contemp Clin Trials] 2025 Dec; Vol. 159, pp. 108116. Date of Electronic Publication: 2025 Oct 24. |
| Způsob vydávání: | Journal Article; Clinical Trial Protocol |
| Jazyk: | English |
| Informace o časopise: | Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: New York, N.Y. : Elsevier, c2005- |
| Výrazy ze slovníku MeSH: | Chronic Pain*/therapy , Chronic Pain*/psychology , Mind-Body Therapies*/methods, Humans ; Medically Underserved Area ; Aged ; Male ; Randomized Controlled Trials as Topic ; Female ; Massachusetts ; Primary Health Care/organization & administration |
| Abstrakt: | Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Background: Older adults in medically underserved areas (MUAs) are disproportionately affected by chronic musculoskeletal pain but lack access to safe, evidence-based psychosocial treatments. Staff at community clinics, where many disadvantaged older adults receive care, must manage complex pain needs and comorbidities with limited time and resources. Shared medical visits integrate medical care, education, and peer support, offering a feasible, scalable solution to overcome barriers associated with chronic pain management in primary care. We previously developed GetActive+, an intervention delivered through shared medical visits at a community clinic to teach mind-body and activity skills to older adults with chronic pain. Here, we describe the protocol for a fully powered hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) comparing GetActive+ to treatment as usual (TAU). Methods: We will recruit 200 English and Spanish-speaking older adult patients from two Massachusetts community clinics located in an MUA. We will assess multimodal physical function and psychosocial outcomes at baseline, post-intervention (11 weeks), and follow-up (6 months). Effectiveness will be determined by improvements in self-reported physical function post-intervention compared to TAU. Using mixed methods, we will assess implementation outcomes (feasibility, acceptability, fidelity, and adoption) at patient, provider, and organizational levels. Results: The trial is ongoing. We have enrolled 54 older adults, 21 of whom have completed post-intervention assessments. Conclusion: We describe the implementation and evaluation of a mind-body activity intervention for older adults with chronic pain using shared medical visits. Results will inform subsequent implementation and dissemination efforts of GetActive+ in community clinics across the United States. Clinical Trials Registration Number: NCT06119698. (Copyright © 2025. Published by Elsevier Inc.) |
| Contributed Indexing: | Keywords: Chronic pain; English and Spanish-speaking; Medically underserved; Mind-body; Older adults; Physical function |
| Molecular Sequence: | ClinicalTrials.gov NCT06119698 |
| Entry Date(s): | Date Created: 20251201 Date Completed: 20251201 Latest Revision: 20251201 |
| Update Code: | 20251202 |
| DOI: | 10.1016/j.cct.2025.108116 |
| PMID: | 41326265 |
| Databáze: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br />Background: Older adults in medically underserved areas (MUAs) are disproportionately affected by chronic musculoskeletal pain but lack access to safe, evidence-based psychosocial treatments. Staff at community clinics, where many disadvantaged older adults receive care, must manage complex pain needs and comorbidities with limited time and resources. Shared medical visits integrate medical care, education, and peer support, offering a feasible, scalable solution to overcome barriers associated with chronic pain management in primary care. We previously developed GetActive+, an intervention delivered through shared medical visits at a community clinic to teach mind-body and activity skills to older adults with chronic pain. Here, we describe the protocol for a fully powered hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) comparing GetActive+ to treatment as usual (TAU).<br />Methods: We will recruit 200 English and Spanish-speaking older adult patients from two Massachusetts community clinics located in an MUA. We will assess multimodal physical function and psychosocial outcomes at baseline, post-intervention (11 weeks), and follow-up (6 months). Effectiveness will be determined by improvements in self-reported physical function post-intervention compared to TAU. Using mixed methods, we will assess implementation outcomes (feasibility, acceptability, fidelity, and adoption) at patient, provider, and organizational levels.<br />Results: The trial is ongoing. We have enrolled 54 older adults, 21 of whom have completed post-intervention assessments.<br />Conclusion: We describe the implementation and evaluation of a mind-body activity intervention for older adults with chronic pain using shared medical visits. Results will inform subsequent implementation and dissemination efforts of GetActive+ in community clinics across the United States.<br />Clinical Trials Registration Number: NCT06119698.<br /> (Copyright © 2025. Published by Elsevier Inc.) |
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| ISSN: | 1559-2030 |
| DOI: | 10.1016/j.cct.2025.108116 |