Family CaregivingNCT04428034

Learning Skills Together Pilot Study

A study testing Learning Skills Together in people with Family Caregiving and Complex Care, run by The University of Texas Health Science Center at San Antonio 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

The Learning Skills Together (LST) program is a synchronous web-based educational intervention developed to address the essential need for training to equip family caregivers to someone with mid-stage Alzheimer's disease to confidently provide complex care tasks.The purpose of this pilot study is to evaluate the… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Family Caregiving, Complex Care, Self Efficacy
What is being tested?: Learning Skills Together
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 3 Sep 2020to 9 Sep 2021
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

Family member (including families of choice) to an individual living with Alzheimer's disease who has received a diagnosis from a physician
Ages 18 and old
Provides assistance with at least two instrumental activities of daily living or one activity of daily living
Care recipient is described as being within mid-stage Alzheimer's Disease
There are no plans to place the care recipient in a skilled nursing facility within the next 3 months

Who cannot join

The caregiver is paid to provide care
The caregiver does not have reliable access to a computer and internet
The caregiver is unable to read and speak English

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Health San Antonio
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Pilot Evaluation of Learning Skills Together: A Intervention to Teach Complex Care Skills to Caregivers of Persons Living With Alzheimer's Disease

Conditions: Family Caregiving, Complex Care, Self Efficacy, Intervention
Being tested: Learning Skills Together

What participants receive

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

Learning Skills TogetherBehavioural
Information provided in arm/group description.

Study groups in NCT04428034
Study group	Role	What they receive
Learning Skills Together Intervention	Experimental	Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals. Receives: Behavioral: Learning Skills Together

What is being measured

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

Change in Caregiver Competency
This will be measured using the Caregiving Competence Scale. This measure includes 3-items pertaining to caregiver's confidence (e.g., "I feel confident that I am meeting the needs of my relative"). There are five response options to each statement ("Strongly Disagree" [1] to "Strongly Agree" [5]), such that scores may range from 3 to 15. A lower score indicates a lower level of confidence that the caregiver is meeting their relative's needs (i.e., higher scores are better). The outcome measure will use the average change score from baseline scores.
Measured: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention
Change in Caregiver Mastery
This will be measured using the Caregiver Mastery Scale. This 7-item scale asks participants the extent to which they feel they have control over various parts of their lives (e.g., "I have little control over the things that happen to me"). Participants may respond that they "Strongly Disagree (1) to Strongly agree (4) with each statement, such that scores range from 7 to 28. The lower the score, the less control the caregiver feels that they have control (i.e., higher scores are better). The mean score for this measure among caregivers to frail older adults was previously reported as 19.42 (SD 3.29), with Cronbach's alpha of 0.78. The outcome measure will use the average change score from baseline scores.
Measured: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention

Timeline

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

3 Sep 20209 Sep 2021

First posted11 Jun 2020
Study start3 Sep 2020
Primary completion15 Aug 2021
Study completion9 Sep 2021

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 (4)Papers the sponsor has linked to this study.
Other trials for Family CaregivingStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: A pre- and post-test design to test the Learning Skills Together program will be employed.
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04428034
Sponsor's protocol ID: HSC20200410H
Status last verified: Mar 2023
First submitted: 9 Jun 2020
Last updated: 21 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: De-identified study data will be made available to other researchers if requested.

Publications

Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
PubMed 649936
Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.
PubMed 2276631
Chan EY, Glass G, Chua KC, Ali N, Lim WS. Relationship between Mastery and Caregiving Competence in Protecting against Burden, Anxiety and Depression among Caregivers of Frail Older Adults. J Nutr Health Aging. 2018;22(10):1238-1245. doi: 10.1007/s12603-018-1098-1.
PubMed 30498832
Robertson, SM, Zarit, SH, Duncan, LG, Rovine, MJ, & Femia, EE. Family caregivers' patterns of positive and negative affect. Family Relations. 2007; 56(1): 12-23.

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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Peer Support for Family Caregivers of Older Adults Living With Dementia
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Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)
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RecruitingObservational study
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Recruiting
Effectiveness of Chatbot for Improving Caregiving Outcomes in Primary Caregivers of Geriatric Pneumonia Patients: A Study on Knowledge, Attitude and Practice.
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Active, not recruiting
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All Family Caregiving trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Evaluation of Learning Skills Together: A Intervention to Teach Complex Care Skills to Caregivers of Persons Living With Alzheimer's Disease
ClinicalTrials.gov ID: NCT04428034
Acronym / sponsor ID: HSC20200410H
Conditions: Family Caregiving, Complex Care, Self Efficacy, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Study start: 3 Sep 2020 (actual)
Primary completion: 15 Aug 2021 (actual)
Study completion: 9 Sep 2021 (actual)
First posted: 11 Jun 2020 (actual)
Results: Posted 4 Mar 2022

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A pre- and post-test design to test the Learning Skills Together program will be employed.

Arm	Type	Receives
Learning Skills Together Intervention	Experimental	Behavioral: Learning Skills TogetherParticipants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Family member (including families of choice) to an individual living with Alzheimer's disease who has received a diagnosis from a physician
Ages 18 and old
Provides assistance with at least two instrumental activities of daily living or one activity of daily living
Care recipient is described as being within mid-stage Alzheimer's Disease
There are no plans to place the care recipient in a skilled nursing facility within the next 3 months

Key exclusion criteria (3 listed)

The caregiver is paid to provide care
The caregiver does not have reliable access to a computer and internet
The caregiver is unable to read and speak English

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
Learning Skills TogetherInformation provided in arm/group description.	Behavioural	Learning Skills Together Intervention

Primary outcome

Change in Caregiver Competency
Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention
This will be measured using the Caregiving Competence Scale. This measure includes 3-items pertaining to caregiver's confidence (e.g., "I feel confident that I am meeting the needs of my relative"). There are five response options to each statement ("Strongly Disagree" [1] to "Strongly Agree" [5]), such that scores may range from 3 to 15. A lower score indicates a lower level of confidence that the caregiver is meeting their relative's needs (i.e., higher scores are better). The outcome measure will use the average change score from baseline scores.
Change in Caregiver Mastery
Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention
This will be measured using the Caregiver Mastery Scale. This 7-item scale asks participants the extent to which they feel they have control over various parts of their lives (e.g., "I have little control over the things that happen to me"). Participants may respond that they "Strongly Disagree (1) to Strongly agree (4) with each statement, such that scores range from 7 to 28. The lower the score, the less control the caregiver feels that they have control (i.e., higher scores are better). The mean score for this measure among caregivers to frail older adults was previously reported as 19.42 (SD 3.29), with Cronbach's alpha of 0.78. The outcome measure will use the average change score from baseline scores.

Results and safety

Results posted to the registry on 4 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Learning Skills Together Intervention	41	35

Primary outcome: Change in Caregiver Competency

Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Learning Skills Together Intervention n = 35
4-Weeks Post-Intervention	1.0 (1.6)
8-Weeks Post-Intervention	1.0 (2.2)

Primary outcome: Change in Caregiver Mastery

Time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Learning Skills Together Intervention n = 35
4-Weeks Post-Intervention	0.7 (2.3)
8-Weeks Post-Intervention	0.5 (2.9)

Adverse events

Time frame: Adverse event data were collected over 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Learning Skills Together Intervention	0 of 35 (0%)	3 of 35 (8.6%)	1 of 35

Limitations and caveats (from the sponsor): Application of a. pre- and post-test design means that changes in self-efficacy cannot be attributed to the intervention alone Results from this study are subject to selection bias given participant dropout between survey collection times The small size of the analytic sample may have contributed to Type II error for some outcomes

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 649936Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
Background: PubMed 2276631Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.
Background: PubMed 30498832Chan EY, Glass G, Chua KC, Ali N, Lim WS. Relationship between Mastery and Caregiving Competence in Protecting against Burden, Anxiety and Depression among Caregivers of Frail Older Adults. J Nutr Health Aging. 2018;22(10):1238-1245. doi: 10.1007/s12603-018-1098-1.
BackgroundRobertson, SM, Zarit, SH, Duncan, LG, Rovine, MJ, & Femia, EE. Family caregivers' patterns of positive and negative affect. Family Relations. 2007; 56(1): 12-23.
Individual participant dataSharing planned: No. De-identified study data will be made available to other researchers if requested.

Related trials for Family Caregiving

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Not yet recruiting
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RecruitingObservational study
Caregiving Networks Across Disease Context and the Life Course
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Recruiting
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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.

Carole L White, PhD, RN principal investigator

The University of Texas Health Science Center at San Antonio

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

Questions about this trial

What is this clinical trial studying?

A study testing Learning Skills Together in people with Family Caregiving and Complex Care, run by The University of Texas Health Science Center at San Antonio 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 5 inclusion and 3 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 21 Mar 2023. 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?

Yes. Results are posted in the registry (first posted 4 Mar 2022). 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 Competency (time frame: Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention). The study lists 2 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 NCT04428034, which also lists 4 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 21 Mar 2023.