Alzheimer's DiseasePhase 2/3NCT00416078

Online Caregiver Psychoeducation and Support for Alzheimer's

A Phase 2/3 study testing caregiver website support and caregiver brief supportive phone calls in people with Alzheimer's Disease, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: caregiver website support and caregiver brief supportive phone calls
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Dec 2012
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient living in community and ambulatory
Patient has diagnosis of Alzheimer's disease
Patient age 50-95
Caregiver age 18-90
Patient currently under treatment for Alzheimer's disease
Patient and caregiver reside within 2 hours of Los Angeles
Caregiver has home internet access
Patient has close contact with caregiver

Who cannot join

Patient lives in residential setting
No family contact
Acute illness or chronic disease in patient or caregiver
Patient or caregiver plans to leave area within the year

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD

This study is piloting an internet-based intervention to provide support for caregivers of VA patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a clinical diagnosis of ADRD and their caregiver/relatives will be randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly brief telephone calls with project staff for six month. It is hypothesized that participation in the intensive intervention will result in a reductions in patient problematic behavior and caregiver responses to it, reduced caregiver burden and depression, and improved medication adherence at the end of treatment, and more patients remaining at home through the 12 months post-randomization period..

Read the detailed description

Alzheimer's disease (AD) is a progressive brain disease resulting in cognitive and functional decline. While some pharmacological agents and behavioral programs are now available to slow the rate of decline, there is no cure. Caregivers, who typically are the female spouses or daughters of afflicted individuals, must confront both the deterioration of a loved one, and that person's need for increasingly demanding care. Caregivers tend to experience high levels of depression, anxiety, and burden. Data suggest that providing education, social support, and ongoing professional consultation to families involved in the care of a relative with AD results in improvement in caregiver psychological status, and sometimes even slows the functional decline of the patient.

Recent technological advancements in video conferencing, online communication, and streaming audio/video presentations, which are increasingly easy to use and gaining widespread acceptance among mental health professionals as well as the public, have given rise to a great deal of interest in telemedicine and telepsychiatry. This study tested an Internet-based family intervention for AD that relatives can access from their homes with ease, and at no cost. In addition to improving patient outcomes through instruction of effective behavioral management, we proposed that participation in an Internet program would also reduce caregiver depression and burden. Fifty-three veterans with a clinical diagnosis of AD and their caregiver/relatives were randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly brief telephone calls with project staff for 6 months. We hypothesized that, at the end of the active intervention, participation in the intensive intervention would result reduced patient problematic behavior, caregiver burden, depression, and negative responses to problematic patient behaviors, as well as improved patient medication compliance. At 12 month follow-up, we hypothesized access to the online program would result in more patients remaining at home. The overriding longterm project objective was to develop an effective online education and support program for caregivers of patients with AD that can be manualized, replicated, and disseminated to other clinical and research centers, within both the VA health care system and the community, to enhance the efficiency and effectiveness of psychosocial treatment in AD.

Conditions: Alzheimer's Disease
Being tested: caregiver website support, caregiver brief supportive phone calls
Keywords: technology development and assessment, internet, randomized control trial
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

caregiver website supportBehavioural
caregiver access to website support for 6 months embedded in one year of customary care
caregiver brief supportive phone callsBehavioural
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care

Study groups in NCT00416078
Study group	Role	What they receive
caregiver website support	Experimental	caregiver access to website support for 6 months embedded in one year of customary care Receives: Behavioral: caregiver website support
caregiver brief supportive phone calls	Active comparator	caregiver brief supportive telephone calls for 6 months embedded in one year of customary care Receives: Behavioral: caregiver brief supportive phone calls

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Caregiver Burden From Baseline
Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.
Measured: baseline to end-of-treatment (6 months)
Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.
Measured: baseline to end of treatment (6 months)
Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver's level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.
Measured: baseline to end of treatment (6 months)
Change in Caregiver Depression From Baseline
Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression
Measured: baseline to end-of-treatment (6 months)

Secondary outcomes (1)

Change in Caregiver Report of Patient Medication Adherence From Baseline
Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.
Measured: baseline to end-of-treatment (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Dec 2012

First posted27 Dec 2006 (estimated)
Study startAug 2007
Primary completionJun 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00416078
Sponsor's protocol ID: IIR 05-107
Status last verified: Apr 2015
First submitted: 22 Dec 2006
Last updated: 29 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hayden LJ, Glynn SM, Hahn TJ, Randall F, Randolph E. The use of Internet technology for psychoeducation and support with dementia caregivers. Psychol Serv. 2012 May;9(2):215-8. doi: 10.1037/a0027056.
PubMed 22662739
Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
PubMed 33417236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD
ClinicalTrials.gov ID: NCT00416078
Acronym / sponsor ID: IIR 05-107
Conditions: Alzheimer's Disease
Keywords: technology development and assessment, internet, randomized control trial
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Aug 2007
Primary completion: Jun 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 27 Dec 2006 (estimated)
Results: Posted 29 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
caregiver website support	Experimental	Behavioral: caregiver website supportcaregiver access to website support for 6 months embedded in one year of customary care
caregiver brief supportive phone calls	Active comparator	Behavioral: caregiver brief supportive phone callscaregiver brief supportive telephone calls for 6 months embedded in one year of customary care

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient living in community and ambulatory
Patient has diagnosis of Alzheimer's disease
Patient age 50-95
Caregiver age 18-90
Patient currently under treatment for Alzheimer's disease

Key exclusion criteria (4 listed)

Patient lives in residential setting
No family contact
Acute illness or chronic disease in patient or caregiver
Patient or caregiver plans to leave area within the year

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
caregiver website supportcaregiver access to website support for 6 months embedded in one year of customary care	Behavioural	caregiver website support
caregiver brief supportive phone callscaregiver brief supportive telephone calls for 6 months embedded in one year of customary care	Behavioural	caregiver brief supportive phone calls

Primary outcome

Change in Caregiver Burden From Baseline
Time frame: baseline to end-of-treatment (6 months)
Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.
Change in Frequency of Patient Problematic Behavioral Patterns From Baseline
Time frame: baseline to end of treatment (6 months)
Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.
Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline
Time frame: baseline to end of treatment (6 months)
Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver's level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.
Change in Caregiver Depression From Baseline
Time frame: baseline to end-of-treatment (6 months)
Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression

1 secondary outcome

Change in Caregiver Report of Patient Medication Adherence From Baseline
Time frame: baseline to end-of-treatment (6 months)

Results and safety

Results posted to the registry on 29 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caregiver Website	29	18
Caregiver Phone Calls	24	16

Primary outcome: Change in Caregiver Burden From Baseline

Time frame: baseline to end-of-treatment (6 months). Least squares mean (Standard Error). Unit: units on a scale

Measure	Caregiver Website n = 20	Caregiver Phone Calls n = 19
baseline	32.04 (1.95)	28.59 (2.01)
end of treatment	32.52 (2.13)	27.55 (2.19)

Caregiver Website vs Caregiver Phone Calls: p = .51, Mixed Models Analysis

Population analysed: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)

Primary outcome: Change in Frequency of Patient Problematic Behavioral Patterns From Baseline

Time frame: baseline to end of treatment (6 months). Least squares mean (Standard Error). Unit: units on a scale

Measure	Caregiver Website n = 20	Caregiver Phone Calls n = 20
baseline	30.69 (2.89)	33.04 (2.99)
end-of-treatment (6 months)	33.28 (3.11)	34.75 (3.27)

Caregiver Website vs Caregiver Phone Calls: p = .79, Mixed Models Analysis

Population analysed: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)

Primary outcome: Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline

Time frame: baseline to end of treatment (6 months). Least squares mean (Standard Error). Unit: units on a scale

Measure	Caregiver Website n = 20	Caregiver Phone Calls n = 20
baseline	16.04 (3.00)	19.09 (3.08)
end-of-treatment (6 months)	20.23 (3.38)	20.08 (3.57)

Caregiver Website vs Caregiver Phone Calls: p = .49, Mixed Models Analysis

Population analysed: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)

Primary outcome: Change in Caregiver Depression From Baseline

Time frame: baseline to end-of-treatment (6 months). Least squares mean (Standard Error). Unit: units on a scale

Measure	Caregiver Website n = 19	Caregiver Phone Calls n = 21
baseline	9.27 (1.54)	9.20 (1.63)
end of treatment	8.61 (1.73)	9.43 (1.83)

Caregiver Website vs Caregiver Phone Calls: p = .67, Mixed Models Analysis

Population analysed: Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline through 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caregiver Website Support	4 of 29 (13.8%)	0 of 29 (0%)	Not reported
Caregiver Brief Supportive Phone Calls	5 of 24 (20.8%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22662739Hayden LJ, Glynn SM, Hahn TJ, Randall F, Randolph E. The use of Internet technology for psychoeducation and support with dementia caregivers. Psychol Serv. 2012 May;9(2):215-8. doi: 10.1037/a0027056.
Derived from this study: PubMed 33417236Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.

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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.

Theodore J. Hahn, MD principal investigator

VA Greater Los Angeles Healthcare System, West LA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing caregiver website support and caregiver brief supportive phone calls in people with Alzheimer's Disease, run by US Department of Veterans Affairs 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 8 inclusion and 4 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 29 Apr 2015. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Caregiver Burden From Baseline (time frame: baseline to end-of-treatment (6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00416078, which also lists 2 linked publications.

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 29 Apr 2015.