NCT02300584

Brief Summary

The purpose of this study is to refine and test the web-based delivery of a well-established in-person group program that provides information and education to informal caregivers (family and friends) of persons with Alzheimer's disease (or related illnesses).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

November 21, 2014

Last Update Submit

September 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)

    6 weeks

Secondary Outcomes (9)

  • Change in Zarit Burden Interview Score

    Baseline, 6 weeks

  • Change in Center for Epidemiological Studies-Depression Scale Score

    Baseline, 6 weeks

  • Change in State Trait Anxiety Index (STAI) Score

    Baseline, 6 weeks

  • Change in Connor Davidson Resilience Scale (CD-RISC)

    Baseline, 6 weeks

  • Change in Perceived Stress Scale

    Baseline, 6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Prototype Program

EXPERIMENTAL

The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period. Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad. Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.

Behavioral: Tele-SavvyOther: iPad

Field Program

EXPERIMENTAL

The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period. Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad. Based on the feedback from the prototype program, the videos may vary. Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.

Behavioral: Tele-SavvyOther: iPad

Interventions

Tele-SavvyBEHAVIORAL

as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)

Prototype Program
iPadOTHER

a tablet computer with an internet connection

Field ProgramPrototype Program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • an informal caregiver for a person with a dementing disorder, such as Alzheimer's disease
  • able to speak, read, and understand English
  • has access to a computer with internet connection
  • lives in the US

You may not qualify if:

  • unwilling to participate in data gathering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Alzheimer's Disease Research Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDepression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Study Officials

  • Kenneth Hepburn, Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kenneth Hepburn PhD

Study Record Dates

First Submitted

November 21, 2014

First Posted

November 25, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations