The Healthy Patterns Sleep Study

NCT03682185 | Completed Phase 3 Results DMC

• 2 other identifiers: 8250001R01NR015226-01A1
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease; Circadian Rhythm Disorders; Circadian Rhythm Sleep Disorder; Insomnia; Hypersomnia; Cognitive Impairment; Cognitive Decline; Mild Cognitive Impairment; Frontotemporal Dementia; Neurocognitive Disorders; Vascular Dementia; Sleep Disorder; Memory Impairment

Keywords

Neuropsychiatric Behaviors; Agitation; Alzheimer's Disease; Dementia

Outcome Measures

Primary Outcomes (1)

• Change in the Quality of Life in Alzheimer's Disease (QOL-AD) Scale

  Person living 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. Total scores are calculated by summing all domain scores. The total score range is 13 to 52, with higher scores indicating higher quality of life. Total scores were analyzed to see if there was a change from baseline to one month. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. Change scores are reported.

  Baseline and 1 month

Secondary Outcomes (1)

• Neuropsychiatric Inventory (NPI)

  4 Months

Other Outcomes (1)

• Circadian Rhythm Symptoms From Actigraphy

  30 days

Study Arms (2)

Timed Activity Intervention Protocol

EXPERIMENTAL

The timed activity group will involve 4 in-home visits and 4 brief telephone education sessions provided over 4 weeks. The timed activity intervention provides activities delivered at specific times in the daily cycle. The in-home sessions are spaced weekly so that the participants can have the opportunity to practice the activity with the interventionist and then on their own. During each session, the interventionist will reinforce activity use, review problem solving approaches, and provide education.

Behavioral: Timed Activity Intervention

Attention-Control Condition

ACTIVE COMPARATOR

This condition will contain no active elements beyond its nonspecific components, and no theoretical basis to support an effect on CRDs. The attention-control group will also involve 4 in-home visits and 4 brief telephone education sessions. The attention control group will receive printed educational and training materials from the Alzheimer's Association and the NIH on home modification, health promotion, talking to your doctor, and advanced care planning that coincide with session content.

Behavioral: Attention-Control Condition

Interventions

Attention-Control Condition BEHAVIORAL

This condition will contain no active elements beyond its nonspecific components, and no theoretical basis to support an effect on CRDs. The attention-control group will also involve 4 in-home visits and 4 brief telephone education sessions. The attention control group will receive printed educational and training materials from the Alzheimer's Association and the NIH on home modification, health promotion, talking to your doctor, and advanced care planning that coincide with session content.

Attention-Control Condition

Timed Activity Intervention BEHAVIORAL

The timed activity group will involve 4 in-home visits and 4 brief telephone education sessions provided over 4 weeks. The timed activity intervention provides activities delivered at specific times in the daily cycle. The in-home sessions are spaced weekly so that the participants can have the opportunity to practice the activity with the interventionist and then on their own. During each session, the interventionist will reinforce activity use, review problem-solving approaches, and provide education.

Timed Activity Intervention Protocol

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be over age 60
• English speaking
• be able to tolerate wrist actigraphy (wear a watch on their wrist for a month)
• diagnosed with dementia using standard assessments and diagnostic criteria
• has CG reporting the presence of CRD symptoms
• 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
• CG is at least 18 years old
• CG lives close to the participant
• CG is planning to live in the area for at least 6 months
• If CG is on a psychotropic medication, CG must be on a stable dose for at least 60 days

You may not qualify if:

• deemed to be in a crisis/unsafe situation at baseline
• reported planned transition to another residential or care setting in less than 6 months
• at end-stage disease (defined as bed-bound and noncommunicative, or on hospice at baseline)
• currently enrolled in an interventional clinical trial for dementia or associated symptoms
• regular use of medications with substantial known effects on the measurement of HPA activity (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy)
• major surgery in the past 3 months
• history of major psychiatric and/or personality disorder
• history of heavy cigarette smoking (e.g. than 50 pack years)
• loss of a loved one in the past 3 months
• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

• 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.

  PMID: 24378361 BACKGROUND

• 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.

  PMID: 20921879 BACKGROUND

• 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.

  PMID: 18370580 BACKGROUND

• 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.

  PMID: 29361067 BACKGROUND

• 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.

  PMID: 29161539 BACKGROUND

• 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.

  PMID: 27986794 BACKGROUND

• 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.

  PMID: 27339865 BACKGROUND

• Hodgson NA, Gooneratne N, Perez A, Talwar S, Huang L. A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial. BMC Geriatr. 2021 Aug 3;21(1):451. doi: 10.1186/s12877-021-02397-2.

  PMID: 34344312 DERIVED

• Hwang Y, Connell LM, Rajpara AR, Hodgson NA. Impact of COVID-19 on Dementia Caregivers and Factors Associated With their Anxiety Symptoms. Am J Alzheimers Dis Other Demen. 2021 Jan-Dec;36:15333175211008768. doi: 10.1177/15333175211008768.

  PMID: 33853394 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence; Cognitive Dysfunction; Frontotemporal Dementia; Neurocognitive Disorders; Dementia, Vascular; Sleep Wake Disorders; Memory Disorders; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Dyssomnias; Occupational Diseases; Sleep Disorders, Intrinsic; Cognition Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Nancy A. Hodgson
• Organization: University of Pennsylvania

hodgsonn@nursing.upenn.edu

215-573-7387

Study Officials

• Nancy A. Hodgson

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: September 24, 2018
• Study Start: May 1, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)