Alzheimer Disease Clinical Trial
Official title:
The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study
NCT number | NCT03682185 |
Other study ID # | 825000 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 1, 2016 |
Est. completion date | May 31, 2021 |
Verified date | July 2021 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Healthy Patterns Study intervention is a home-based activity intervention designed to improve symptoms of circadian rhythm disorders (CRD) and quality of life (QOL) in home-dwelling persons with dementia. We will use a randomized two-group parallel design of 200 people with dementia and their caregivers assigned to intervention or attention control groups.
Status | Completed |
Enrollment | 210 |
Est. completion date | May 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Inclusion criteria for care receiver (CR): 1. be over age 60 2. English speaking 3. be able to tolerate wrist actigraphy (wear a watch on their wrist for a month) 4. diagnosed with dementia using standard assessments and diagnostic criteria 5. has CG reporting the presence of CRD symptoms 6. If the CR is on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), we will require that the CR have been on a stable dose for 90 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications Inclusion criteria for caregiver (CG): 1. CG is at least 18 years old 2. CG lives close to the participant 3. CG is planning to live in the area for at least 6 months 4. If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days Exclusion criteria for CR: 1. deemed to be in a crisis/unsafe situation at baseline 2. reported planned transition to another residential or care setting in less than 6 months 3. at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline) 4. currently enrolled in an interventional clinical trial for dementia or associated symptoms 5. regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy) 6. major surgery in the past 3 months 7. history of major psychiatric and/or personality disorder 8. history of heavy cigarette smoking (e.g. than 50 pack years) 9. loss of a loved one in the past 3 months 10. conditions known to affect measurement of circadian rhythm such as use of sedatives/ hypnotics, Huntington's disease, Cushing's disease, Addison's disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI 35) |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Gitlin LN, Piersol CV, Hodgson N, Marx K, Roth DL, Johnston D, Samus Q, Pizzi L, Jutkowitz E, Lyketsos CG. Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial. Contemp Clin Trials. 2016 Jul;49:92-102. doi: 10.1016/j.cct.2016.06.006. Epub 2016 Jun 21. — View Citation
Hirschman KB, Hodgson NA. Evidence-Based Interventions for Transitions in Care for Individuals Living With Dementia. Gerontologist. 2018 Jan 18;58(suppl_1):S129-S140. doi: 10.1093/geront/gnx152. Review. — View Citation
Hodgson NA, Andersen S. The clinical efficacy of reflexology in nursing home residents with dementia. J Altern Complement Med. 2008 Apr;14(3):269-75. doi: 10.1089/acm.2007.0577. — View Citation
Hodgson NA, Gitlin LN, Winter L, Czekanski K. Undiagnosed illness and neuropsychiatric behaviors in community residing older adults with dementia. Alzheimer Dis Assoc Disord. 2011 Apr-Jun;25(2):109-15. doi: 10.1097/WAD.0b013e3181f8520a. — View Citation
Hodgson NA, Granger DA. Collecting saliva and measuring salivary cortisol and alpha-amylase in frail community residing older adults via family caregivers. J Vis Exp. 2013 Dec 18;(82):e50815. doi: 10.3791/50815. — View Citation
Regier NG, Hodgson NA, Gitlin LN. Characteristics of Activities for Persons With Dementia at the Mild, Moderate, and Severe Stages. Gerontologist. 2017 Oct 1;57(5):987-997. doi: 10.1093/geront/gnw133. — View Citation
Samus QM, Black BS, Bovenkamp D, Buckley M, Callahan C, Davis K, Gitlin LN, Hodgson N, Johnston D, Kales HC, Karel M, Kenney JJ, Ling SM, Panchal M, Reuland M, Willink A, Lyketsos CG. Home is where the future is: The BrightFocus Foundation consensus panel on dementia care. Alzheimers Dement. 2018 Jan;14(1):104-114. doi: 10.1016/j.jalz.2017.10.006. Epub 2017 Nov 21. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circadian Rhythm Symptoms from actigraphy | Measured using a Motionlogger actigraphy bracelet worn by CR for consecutive 24-hour periods for one whole month.
Actigraphic measures of physical activity do not rely on participant self-report and may be of particular importance for efforts to examine the health benefits of physical activity across the full spectrum of older individuals especially those with dementia, a group in which loss of motor function is particularly salient. |
30 days | |
Primary | The Quality of Life in Alzheimer's Disease Scale (QOL-AD) | Person with dementia quality of life. The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks. | Baseline and 4 months | |
Secondary | Neuropsychiatric Inventory (NPI) | Neuropsychiatric Behaviors The Neuropsychiatric Inventory Questionnaire (NPI) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress.
Neuropsychiatric symptoms are rated by the caregiver within a domain in terms of both frequency (1=rarely, less than once per week; 2=sometimes, about once per week; 3=often, several times per week; and 4=very often, once or more per day) and severity (1=mild; 2=moderate; 3=severe), thus yielding a composite symptom domain score (frequency × severity) ranging from 0 (absence of behavioral symptoms) to 144 points (maximum severity of behavioral symptoms). |
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