Improving Sleep in Veterans and Their CGs

NCT02057068 | Completed Results

• 1 other identifier: E7249-W
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at home and being cared for by a family caregiver (CG). The purpose of the study was to develop and field test non-pharmacological, technology enhanced sleep hygiene, exercise and meditation interventions to improve sleep in Veteran caregiving dyads.The conceptual framework of the intervention incorporated components of cognitive behavioral therapy, psycho-education and self-management support for individuals with chronic conditions with an emphasis on cultivating competence and mastery.

Conditions

Sleep Quality

Keywords

Caregivers; Telemedicine; Sleep Disorders; Meditation; Cognitive Behavioral Therapy; Activity Enhancement; Technology; Non-pharmacological sleep intervention

Outcome Measures

Primary Outcomes (1)

• Subjective Sleep Quality

  Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score \> 5 (some evidence for 8) is indicative of poor sleep quality.

  Baseline (T1) and Post-Intervention (T2) - 8 Weeks

Secondary Outcomes (2)

• Mean Sleep Efficiency

  Baseline (T1) and Post-Intervention (T2) - 8 Weeks

• BEF-SHI Total Number of Negative Sleep Hygiene Behaviors

  Baseline (T1) and Post-Intervention (T2) - 8 Weeks

Study Arms (2)

SLEEP-E Dyads Intervention

EXPERIMENTAL

SLEEP-E Dyads Six-Week Tele-Health Intervention 1. . Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep. 2. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Move Out" time consisting of activity enhancement and exercise. 3. . Daily and on-demand video modules designed to promote and provide guided instruction for daily "Stand Down" time (meditation, therapeutic breathing and self-care). 4. . SLEEP-E Dyads book 5. . Two tele-video conferences to discuss evaluation results, obtain buy-in for the prescribed intervention and address dysfunctional beliefs and attitudes about sleep. The second call involves checking-in, encouragement, reinforcement and coaching

Behavioral: SLEEP-E Dyads Intervention

Usual Care Group

NO INTERVENTION

During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.

Interventions

SLEEP-E Dyads Intervention BEHAVIORAL

Described in arm/group description

SLEEP-E Dyads Intervention

Eligibility Criteria

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

You may qualify if:

• Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,
• have a life expectancy of greater than or equal to six (6) months,
• have no plans for transitioning out of home in the next six months,
• and have approval from the primary care provider to participate in the research.
• Caregivers must live with care recipient
• Caregivers must obtain a negative mini-cog assessment or negative TICS-m assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the care recipient so long as the two are cohabitating.
• Caregiver can be any age.
• For Phase 2 and Phase 3 of the study, either the care recipient or the caregiver must have difficulty sleeping as indicated by scores on the Insomnia Severity Index.

You may not qualify if:

• Parkinson's with tremor or other movement disorder that would invalidate actigraphy
• Untreated diagnosis of sleep apnea or restless leg syndrome
• Inability to tolerate actigraphy
• CG and CR sleep efficiency \> 85% and/or both members of dyad report sleeping well
• Caregivers must have a negative screen with the Mini-Cog or the ModifiedTelephone Interview for Cognitive Status (TICS-M) to demonstrate cognitive capacity to provide informed consent

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Emory University: collaborator

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot and feasibility study involving dyads who self-selected into the program. The sample size is small, thus the results should be interpreted with caution.

Results Point of Contact

• Title: Patricia C. Griffiths, PhD
• Organization: Atlanta Department of Veterans Affairs Medical Center CVNR

pcgriff@emory.edu

6783615462

Study Officials

• Patricia C Griffiths, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This efficacy study was not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomization to an immediate intervention group or a no-contact wait list control group. Following post intervention assessments the wait-list control group received the intervention.

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: February 6, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 23, 2018
• Results First Posted: December 5, 2017

Record last verified: 2017-12

Locations

US (1)