DementiaNCT02300584
Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program
A study testing Tele-Savvy and iPad in people with Dementia and Alzheimer's Disease, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease, Depression
- What is being tested?
- Tele-Savvy and iPad
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unwilling to participate in data gathering
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, 30329
About this study
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).
Read the detailed description
The pilot project proposed will allow the investigators to use telehealth methods to deliver the Savvy Caregiver, an evidence-based dementia caregiver psychoeducation program, to family caregivers of community-dwelling persons with dementing illnesses (PWD) for whom attending in-person meetings poses difficulties. The program - named Tele-Savvy - uses iPad and PC technology and on-line conferencing capacity to deliver the program through daily asynchronous self-learning modules and weekly, hour-long synchronous group meetings with program facilitators. Tele-Savvy addresses all of the learning objectives of the current in-person Savvy program (Savvy entails in-person participation in six weekly two-hour group sessions).
- Conditions
- Dementia, Alzheimer's Disease, Depression
- Being tested
- Tele-Savvy, iPad
- Medical subject headings
- Dementia, Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-SavvyBehavioural
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)
Tele-SavvyBehavioural
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each). Videos may be modified after feedback from Prototype arm.
iPadOther
a tablet computer with an internet connection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tele-Savvy; Other: 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. Receives: Behavioral: Tele-Savvy; Other: iPad |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)
Measured: 6 weeks
Secondary outcomes (9)
Change in Zarit Burden Interview Score
A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.
Measured: Baseline, 6 weeks
Change in Center for Epidemiological Studies-Depression Scale Score
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Measured: Baseline, 6 weeks
Change in State Trait Anxiety Index (STAI) Score
State Trait Anxiety Index questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: Baseline, 6 weeks
Change in Connor Davidson Resilience Scale (CD-RISC)
The Connor-Davidson Resilience scale (CD-RISC) comprises of 25 items, each rated on a 5-point scale. A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
Measured: Baseline, 6 weeks
Change in Perceived Stress Scale
The Perceived Stress Scale is a 10-item questionnaire, on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.
Measured: Baseline, 6 weeks
Change in Caregiver Self-Efficacy Score
Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.
Measured: Baseline, 6 weeks
Change in Personal Mastery scale
Personal Mastery scale is a seven item, five-point Likert scale. Scoring is done by summing item scores for a total score (possible range 7-35) with higher scores indicating higher levels of mastery.
Measured: Baseline, 6 weeks
Change in Revised Memory and Behavior Problem Checklist
This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.
Measured: Baseline, 6 weeks
Change in Lawton Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) Scale
Lawton ADL/IADL is caregiver reported performance of personal and instrumental activities of daily living (ADLs). There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Hepburn, Emory University
- Investigators
- Kenneth Hepburn, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300584
- Sponsor's protocol ID
- IRB00074715
- Status last verified
- Sep 2016
- First submitted
- 21 Nov 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program
- ClinicalTrials.gov ID
- NCT02300584
- Acronym / sponsor ID
- IRB00074715
- Conditions
- Dementia, Alzheimer's Disease, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The pilot project proposed will allow the investigators to use telehealth methods to deliver the Savvy Caregiver, an evidence-based dementia caregiver psychoeducation program, to family caregivers of community-dwelling persons with dementing illnesses (PWD) for whom attending in-person meetings poses difficulties. The program - named Tele-Savvy - uses iPad and PC technology and on-line conferencing capacity to deliver the program through daily asynchronous self-learning modules and weekly, hour-long synchronous group meetings with program facilitators. Tele-Savvy addresses all of the learning objectives of the current in-person Savvy program (Savvy entails in-person participation in six weekly two-hour group sessions).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prototype Program | Experimental | Behavioral: Tele-Savvy, Other: iPadThe 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. |
| Field Program | Experimental | Behavioral: Tele-Savvy, Other: iPadThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unwilling to participate in data gathering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Savvyas a program delivered on an iPad with daily instructional video segments (8-12 minutes each) | Behavioural | Prototype Program |
| Tele-Savvyas a program delivered on an iPad with daily instructional video segments (8-12 minutes each). Videos may be modified after feedback from Prototype arm. | Behavioural | Field Program |
| iPada tablet computer with an internet connection | Other | Field Program, Prototype Program |
Primary outcome
The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)
Time frame: 6 weeks
9 secondary outcomes
Change in Zarit Burden Interview Score
Time frame: Baseline, 6 weeks
Change in Center for Epidemiological Studies-Depression Scale Score
Time frame: Baseline, 6 weeks
Change in State Trait Anxiety Index (STAI) Score
Time frame: Baseline, 6 weeks
Change in Connor Davidson Resilience Scale (CD-RISC)
Time frame: Baseline, 6 weeks
Change in Perceived Stress Scale
Time frame: Baseline, 6 weeks
Change in Caregiver Self-Efficacy Score
Time frame: Baseline, 6 weeks
Change in Personal Mastery scale
Time frame: Baseline, 6 weeks
Change in Revised Memory and Behavior Problem Checklist
Time frame: Baseline, 6 weeks
Change in Lawton Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) Scale
Time frame: Baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Hepburn, Ph.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Savvy and iPad in people with Dementia and Alzheimer's Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.