Trial record 2 of 4342 for:    sleep

Improving Sleep in Veterans and Their CGs (SLEEP-E Dyads)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02057068
First received: January 24, 2014
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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 first phase of this study is determine the relationship between CG and care recipient (CR) sleep and describe the impact of dyadic sleep to daytime functioning and well-being for Veterans and their caregivers. The information from phase 1 will inform the next study phase in which we develop and field test non-pharmacological, technology based, cognitive behavior therapy and compassion meditation interventions to improve sleep in Veteran caregiving dyads.


Condition Intervention Phase
Sleep Quality
Behavioral: SLEEP-E Dyads Sleep Hygiene and Cognitively Based Compassion Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Sleep In Veterans and Their Family Caregivers

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: Week 6 of 6 Week Intervention ] [ Designated as safety issue: No ]
    Objective measure of sleep efficiency obtained from the wrist actigraphs


Secondary Outcome Measures:
  • Subjective Sleep [ Time Frame: Week 6 of 6 Week Intervention ] [ Designated as safety issue: No ]
    Subjective sleep quality from daily journals

  • Daytime Mood [ Time Frame: Week 6 of 6 week intervention ] [ Designated as safety issue: No ]
    daily measures of mood from journal

  • Sleep Hygiene Behaviors [ Time Frame: Weeks 5 and 6 of 6 Week Intervention ] [ Designated as safety issue: No ]
    Daily sleep hygiene behaviors from e- journals composite of sleep hygiene indicators


Other Outcome Measures:
  • Intervention Adherence [ Time Frame: Daily for 6 Weeks ] [ Designated as safety issue: No ]
    Participation in daily sessions; daily journals - modules viewed


Estimated Enrollment: 260
Study Start Date: November 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
SLEEP-E Dyads Sleep Hygiene and Cognitively Based Compassion Training Intervention
Behavioral: SLEEP-E Dyads Sleep Hygiene and Cognitively Based Compassion Training
Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition to the adaptive prescriptions, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum and compassion meditation training delivered by the E-Tablets.
No Intervention: Usual Care Group
During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veterans 60 who require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activity of Daily Living,
  • have a life expectancy of greater than or equal to six (6) months,
  • have no plans for transitioning out of home or into hospice in the next six months,
  • and have approval from the primary care provider to participate in the research.
  • Caregivers must live with the Veteran, provide care four (4) or more days out of the week for at least 6 months,
  • and obtain a negative mini-cog assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the Veteran so long as the two are co-habitating.
  • Caregiver can be any age.
  • Approval for participation by PCP

Exclusion Criteria:

  • 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 to demonstrate cognitive capacity to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057068

Contacts
Contact: Patricia C Griffiths, PhD (404) 321-6111 ext 7138 pcgriff@emory.edu
Contact: Christine A Towler, MS (404) 321-6111 ext 7093 christine.towler@va.gov

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Patricia C Griffiths, PhD    404-321-6111 ext 7138    pcgriff@emory.edu   
Contact: Christine A Towler, MS    (404) 321-6111 ext 7093    christine.towler@va.gov   
Principal Investigator: Patricia C Griffiths, PhD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Patricia C Griffiths, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02057068     History of Changes
Other Study ID Numbers: E7249-W
Study First Received: January 24, 2014
Last Updated: July 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Caregivers
Telemedicine
Sleep Disorders
Compassion Meditation
Dementia
Cognitive Behavioral Therapy
Meditation
Technology

ClinicalTrials.gov processed this record on August 21, 2014