Caregivers of Alzheimer's Disease or Memory Problem PatientsNCT03049501
Caring for the Caregiver Network
A study testing Caregiving condition and Nutrition condition in people with Caregivers of Alzheimer's Disease or Memory Problem Patients, run by University of Miami at 1 site in United States.
Trial summary
The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers of Alzheimer's Disease or Memory Problem Patients
- What is being tested?
- Caregiving condition and Nutrition condition
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 20 Apr 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speak and understand English or Spanish
- Provide care to a loved one with memory decline
- Not having terminal illness/condition
- 18+ yrs old
Who cannot join
- Not providing care to a loved one with Alzheimer disease or dementia
- Not speak English or Spanish
- Have cognitive deficit
- Have terminal illness
- Plan to place their loved one in a facility
- Plan to move away in the next 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: A Tailored Technology Intervention for Diverse Caregivers of AD Patients
The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.
- Being tested
- Caregiving condition, Nutrition condition
- Keywords
- Alzheimer's caregivers, Technology-based intervention, Culturally-tailored intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiving conditionBehavioural
The intervention will consist of multimedia features accessible via the study-provided tablet. The components include: skill-building sessions and modules; a resource guide; an annotated reading list; information and tips; expert educational seminars (video); and structured support group sessions (6 sessions). All the sessions (home-based, one-on-one, and support group sessions) will last about 60-90 minutes.
Nutrition conditionBehavioural
The intervention will provide resource and information tips on topics related to Nutrition for a total of 8 sessions. The first and last session will be home-based and all the other sessions will be conducted via web-conferencing using the tablet provided.
| Study group | Role | What they receive |
|---|---|---|
| Caregiving Condition | Experimental | Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics Receives: Behavioral: Caregiving condition |
| Nutrition Condition | Placebo comparator | Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition. Receives: Behavioral: Nutrition condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Caregiving Burden as Measured by Burden Inventory
Higher score means greater level of caregiver burden. Range (0-44)
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Caregiver's Self Report of Self-care
A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Caregiver's Self-report of Physical Health
SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Caregiver's Self-efficacy
A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Positive Aspects of Caregiving
An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startJul 2013
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
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.
- Other trials for Caregivers of Alzheimer's Disease or Memory Problem PatientsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, David Loewenstein, University of Miami
- Investigators
- David Loewenstein, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049501
- Sponsor's protocol ID
- 20130460
- Other IDs
- R01NR014434
- Status last verified
- Jun 2019
- First submitted
- 8 Feb 2017
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Technology Intervention for Diverse Caregivers of AD Patients
- ClinicalTrials.gov ID
- NCT03049501
- Acronym / sponsor ID
- 20130460
- Keywords
- Alzheimer's caregivers, Technology-based intervention, Culturally-tailored intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2013
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiving Condition | Experimental | Behavioral: Caregiving conditionParticipants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics |
| Nutrition Condition | Placebo comparator | Behavioral: Nutrition conditionParticipants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Speak and understand English or Spanish
- Provide care to a loved one with memory decline
- Not having terminal illness/condition
- 18+ yrs old
Key exclusion criteria (6 listed)
- Not providing care to a loved one with Alzheimer disease or dementia
- Not speak English or Spanish
- Have cognitive deficit
- Have terminal illness
- Plan to place their loved one in a facility
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 |
|---|---|---|
| Caregiving conditionThe intervention will consist of multimedia features accessible via the study-provided tablet. The components include: skill-building sessions and modules; a resource guide; an annotated reading list; information and tips; expert educational seminars (video); and structured support group sessions (6 sessions). All the sessions (home-based, one-on-one, and support group sessions) will last about 60-90 minutes. | Behavioural | Caregiving Condition |
| Nutrition conditionThe intervention will provide resource and information tips on topics related to Nutrition for a total of 8 sessions. The first and last session will be home-based and all the other sessions will be conducted via web-conferencing using the tablet provided. | Behavioural | Nutrition Condition |
Primary outcome
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Caregiving Burden as Measured by Burden Inventory
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Higher score means greater level of caregiver burden. Range (0-44)
Caregiver's Self Report of Self-care
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.
Caregiver's Self-report of Physical Health
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.
Caregiver's Self-efficacy
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.
Positive Aspects of Caregiving
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Caregivers of Alzheimer's Disease or Memory Problem Patients
Not yet recruiting
Psychological Counseling Program for Alzheimer's Patients' Caregivers
Alzheimer Disease, Caregivers of Alzheimer's Disease or Memory Problem Patients
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.
David Loewenstein, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiving condition and Nutrition condition in people with Caregivers of Alzheimer's Disease or Memory Problem Patients, run by University of Miami 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 6 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 25 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2019). 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?
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) (time frame: Baseline, 6-mth follow-up and 12-mth follow-up). The study lists 6 primary outcomes in all. 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 25 Jun 2019.