Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05600465
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-07-29
Brief Title:
Behavioral Activation Occupational Therapy An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Behavioral Activation Occupational Therapy An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAOT
Brief Summary:
Approximately 45 of older adults in the US have 2 or more chronic health conditions eg arthritis hypertension diabetes in addition to functional limitations that prevent performance of health self-management activities Self-management continues to be the gold standard for managing MCC but functional limitations create difficulty with these activities eg physical activity symptom monitoring Restricted self-management accelerates the downward spiral of disability and accumulating chronic conditions which in turn increases rates of institutionalization and death by 5-fold Currently there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations Research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities especially when contending with complex medical regimens and functional limitations Combined with occupational therapy OT behavioral activation BA shows promise to improve health self-management in populations with chronic conditions andor functional limitations This innovative combination uses the goal setting schedulingmonitoring activities and problem-solving components of the BA approach as well as the environmental modification activity adaptation and focus on daily routines from OT practice The investigators will test the effect of this combined approach in a Stage I randomized controlled pilot feasibility study compared to enhanced usual care The investigators will recruit 40 older adults with MCC and functional limitation and randomize 20 to the PI- delivered BA-OT protocol This research will inform modification and larger-scale testing of this novel intervention and provide data for a federally funded career development award
Detailed Description:
Americans with multiple chronic health conditions MCC are living longer lives but there is a costly tradeoff Approximately 81 of older adults in the US have 2 or more health conditions eg arthritis hypertension diabetes that are long-term and cumulative For these older adults there are direct and positive relationships among age higher number of chronic conditions and higher incidence of disability and functional limitations Because functional limitations interfere with daily health self-management activities eg physical activity managing medications preparing healthy meals and accessing health care MCC ranks high among the disabling and costly conditions of aging For example older adults with MCC perform fewer health self-management activities and attend nearly double the number of outpatient healthcare visits as their peers with fewer or no MCC Besides the high cost difficulties with health self-management accelerate the downward spiral of restricted daily activity and accumulating chronic conditions which in turn increases rates of institutionalization and death by 5-fold
Among the emergent health problems of the 21st century MCC stand out as one of the most challenging to treat not only for the individual but the larger health system as well Pharmacological interventions for MCC ie gero-protectors targeting multiple diseases of aging with one drug have focused on deterring the cascading disease development in this population but do not address limitations in daily health self-management deficits a primary instigator of the downward spiral Thus far non-pharmacological interventions have primarily focused on health care organization exercise and self-management education with null or mixed results Studies have shown that simply providing self-management education is insufficient to facilitate health behavior changes in older age and especially in the presence of functional limitations Often overlooked is the importance of integrating the complicated health self-management activities into daily life routines Indeed research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities This is particularly true when older adults are also contending with functional limitations Currently there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations
Behavioral activation BA an evidence-based behavior change intervention can improve performance in daily activity including health self-management behaviors Combined with occupational therapy OT BA shows promise to improve participation in daily activities in cancer survivors older adults with mild cognitive impairment and individuals with post-stroke functional limitations This innovative combination focuses on the goal setting schedulingmonitoring activities and problem-solving components of the BA approach as well as the environmental modification activity adaptation and focus on daily routines from OT practice BA-OT Due to the complexity of managing MCC in conjunction with functional limitations BA-OT is the ideal approach Paramount to our approach is the execution of daily health self-management activities in participant homes to ensure optimal real-world application The Principal Investigator PI a BA-trained and licensed occupational therapist will deliver BA-OT over 10 weeks 1 sessionwk This is a pilot randomized controlled trial and feasibility study Stage I in which 40 older adults with MCC and functional imitations will be assigned to BA-OT or enhanced usual care comparison group
Specific Aim 1 Collect preliminary data to test the effect of BA-OT for improving independence in health self-management activities for older adults with MCC and functional limitation compared to enhanced usual care Hypothesis Older adults who receive BA-OT will demonstrate improved independence in health self-management activity as measured by the self-report Canadian Occupational Performance Measure and the Self-Management Assessment Scale Rationale Though similar interventions have shown promise in populations with different disease courses BA-OT has not been tested in older adults with MCC and functional limitations
Specific Aim 2 Examine the feasibility of recruitment and conduct of the BA-OT intervention with older adults with MCC and functional limitation Quantitative measures include recruitment rates proportions of participants who initiate and complete the intervention and adherence to study procedures as well as in-depth qualitative information to understand acceptability and suitability of the intervention Rationale Similar interventions have been successful but not with older adults with MCC and functional limitations a group that is difficult to treat The investigators will answer the critical question can it work and seek evidence to inform adaptation to a larger study
Combining these two approaches to address the persistent problem of health self-management in this population is novel and promising This specific combination of active ingredients has potential to prevent functional limitations prevent costly hospitalizations and reduce disability in older adults with MCC This project will inform the modification and testing of BA-OT with a larger sample as well as generating preliminary data for a federally funded career development award
Among the emergent health problems of the 21st century MCC stand out as one of the most challenging to treat not only for the individual but the larger health system as well Pharmacological interventions for MCC ie gero-protectors targeting multiple diseases of aging with one drug have focused on deterring the cascading disease development in this population but do not address limitations in daily health self-management deficits a primary instigator of the downward spiral Thus far non-pharmacological interventions have primarily focused on health care organization exercise and self-management education with null or mixed results Studies have shown that simply providing self-management education is insufficient to facilitate health behavior changes in older age and especially in the presence of functional limitations Often overlooked is the importance of integrating the complicated health self-management activities into daily life routines Indeed research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities This is particularly true when older adults are also contending with functional limitations Currently there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations
Behavioral activation BA an evidence-based behavior change intervention can improve performance in daily activity including health self-management behaviors Combined with occupational therapy OT BA shows promise to improve participation in daily activities in cancer survivors older adults with mild cognitive impairment and individuals with post-stroke functional limitations This innovative combination focuses on the goal setting schedulingmonitoring activities and problem-solving components of the BA approach as well as the environmental modification activity adaptation and focus on daily routines from OT practice BA-OT Due to the complexity of managing MCC in conjunction with functional limitations BA-OT is the ideal approach Paramount to our approach is the execution of daily health self-management activities in participant homes to ensure optimal real-world application The Principal Investigator PI a BA-trained and licensed occupational therapist will deliver BA-OT over 10 weeks 1 sessionwk This is a pilot randomized controlled trial and feasibility study Stage I in which 40 older adults with MCC and functional imitations will be assigned to BA-OT or enhanced usual care comparison group
Specific Aim 1 Collect preliminary data to test the effect of BA-OT for improving independence in health self-management activities for older adults with MCC and functional limitation compared to enhanced usual care Hypothesis Older adults who receive BA-OT will demonstrate improved independence in health self-management activity as measured by the self-report Canadian Occupational Performance Measure and the Self-Management Assessment Scale Rationale Though similar interventions have shown promise in populations with different disease courses BA-OT has not been tested in older adults with MCC and functional limitations
Specific Aim 2 Examine the feasibility of recruitment and conduct of the BA-OT intervention with older adults with MCC and functional limitation Quantitative measures include recruitment rates proportions of participants who initiate and complete the intervention and adherence to study procedures as well as in-depth qualitative information to understand acceptability and suitability of the intervention Rationale Similar interventions have been successful but not with older adults with MCC and functional limitations a group that is difficult to treat The investigators will answer the critical question can it work and seek evidence to inform adaptation to a larger study
Combining these two approaches to address the persistent problem of health self-management in this population is novel and promising This specific combination of active ingredients has potential to prevent functional limitations prevent costly hospitalizations and reduce disability in older adults with MCC This project will inform the modification and testing of BA-OT with a larger sample as well as generating preliminary data for a federally funded career development award
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None