Viewing Study NCT06264362



Ignite Creation Date: 2024-05-06 @ 8:08 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06264362
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-14
First Post: 2023-12-14

Brief Title: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
Sponsor: Drexel University
Organization: Drexel University

Study Overview

Official Title: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
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: None
Brief Summary: The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems This study will include two parts Participants can choose to participate in either or both parts

In Part 1 not a clinical trial - The investigators are inviting the following people to participate in an interview

1 Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain
2 Care partners of people with knee pain and memory issues A care partner can be a family member or friend who helps regularly
3 Clinicians exercise physiologists or rehabilitation therapists like physical and occupational therapists who have worked with older adults with memory issues and knee pain

The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them From these interviews the investigators hope to design a non-drug tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems

For people with memory problems and knee pain and their care partners The investigators will ask some questions to determine eligibility to participate in the study

Those who qualify for the study will be invited to participate in an interview that could be completed online or in person Philadelphia PA The interview could last up to 90 minutes 1 and a half hours and can be completed as one or multiple sessions

For clinicians Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person Those participating in an online focus group will receive a gift card equal to the value of lunch

In Part 2 a clinical trial - The program developed in Part 1 will be tested The program will be physical activity-based Specific program details for part 2 will be provided as they emerge Participants can choose to sign up for either or both parts Signing up for Part 1 does not mean participants have to sign up for Part 2

Please contact us for any questions
Detailed Description: Chronic musculoskeletal pain specifically osteoarthritis OA of the knee is common among community-dwelling people living with memory issues and associated with cascading negative consequences on physical function limitations quality of life decline and caregiver burden however few beneficial and appropriate treatment options exist This study seeks to use evidence theory and stakeholder input to design an exercise-based intervention for knee OA pain management tailored to the interests preserved abilities and biopsychosocial-environmental needs of community-dwelling older adults with mild to very mild dementia Findings from K23 research will yield a nonpharmacological intervention prototype and delivery parameters that will inform a future efficacy study and have a strong potential for preserving or improving the quality of life of community-dwelling older adults with dementia and OA

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?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1K23AG081547-01 NIH None httpsreporternihgovquickSearch1K23AG081547-01