Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623669
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Mobile Intervention to Reduce Pain and Improve Health-III
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Mobile Intervention to Reduce Pain and Improve Health-III
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MORPH-III
Brief Summary:
The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging Unfortunately while as many as three in four older adults experience chronic pain few have access to effective non-pharmacological pain management strategies Participating in regular physical activity avoiding sustained sitting and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss and lasting weight maintenance with pilot data suggesting this may contribute to improved pain physical function and health-related quality of life among older adults with chronic pain As these were NIH Stage I trials there are several important gaps to be addressed in the present trial 1 both studies of chronic pain recruited small samples and were 12 weeks in duration limiting our ability to establish efficacy and the durability of changes to activity HRQOL and pain outcomes 2 participants included anyone with chronic pain regardless of pain type a likely contributor to heterogeneous pain intensity and interference findings and 3 the investigators have yet to examine behavioral maintenance
The overarching goal of the proposed Stage II mobile intervention to reduce pain and improve health-III MORPH-III is to establish the efficacy of the intervention for enhancing physical activity via steps primary and for reducing pain interference and body weight while enhancing physical function secondary among older adults with chronic knee or hip osteoarthritic OA pain The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls This will be followed by a 12-month no-contact maintenance period where participants will attempt to sustain behavioral goals on their own
The Specific Aims are
Specific Aim 1 To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control Hypotheses MORPH will significantly increase steps relative to control at month 6
Specific Aim 2 To examine the impact of MORPH on pain interference change in body weight and physical function relative to the enhanced usual care control Hypotheses MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6
Exploratory Aims Aim 1 To investigate the impact of the MORPH intervention on steps weight change pain interference and physical function at month 18 Aim 2 If the MORPH intervention results in reduced pain interference at 6 andor 18 months the investigators will examine the extent to which 6-month change in steps weight pain self-efficacy and catastrophizing mediate change in interference at 6 andor 18 months
The overarching goal of the proposed Stage II mobile intervention to reduce pain and improve health-III MORPH-III is to establish the efficacy of the intervention for enhancing physical activity via steps primary and for reducing pain interference and body weight while enhancing physical function secondary among older adults with chronic knee or hip osteoarthritic OA pain The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls This will be followed by a 12-month no-contact maintenance period where participants will attempt to sustain behavioral goals on their own
The Specific Aims are
Specific Aim 1 To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control Hypotheses MORPH will significantly increase steps relative to control at month 6
Specific Aim 2 To examine the impact of MORPH on pain interference change in body weight and physical function relative to the enhanced usual care control Hypotheses MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6
Exploratory Aims Aim 1 To investigate the impact of the MORPH intervention on steps weight change pain interference and physical function at month 18 Aim 2 If the MORPH intervention results in reduced pain interference at 6 andor 18 months the investigators will examine the extent to which 6-month change in steps weight pain self-efficacy and catastrophizing mediate change in interference at 6 andor 18 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None