Learning Skills Together Family Caregiver Complex Intervention

NCT ID: NCT05846984

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2027-04-30

Brief Summary

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Learning Skills Together (LST) is a 6-week psychoeducational intervention focused on complex care (nursing) tasks completed by family caregivers to persons living with Alzheimer's Disease and related dementias. This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by building caregiver self-efficacy. To do this, eligible participants will be randomized into an intervention group (LST) or a control group condition focused on healthy living for family caregivers. Participants will be asked to complete surveys before and after participating in the intervention or the control condition to determine whether change in hypothesized outcomes can be attributed to the intervention condition.

Detailed Description

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Conditions

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Dementia Alzheimer Disease Caregiver Burden Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
In this study, participants, intervention facilitators, and the PI will be unblinded. Individuals collecting follow up surveys will be blinded to treatment condition, as will the study's statistician and data manager.

Study Groups

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Learning Skills Together Intervention

Complex care psychoeducation training intervention for family caregivers

Group Type EXPERIMENTAL

Learning Skills Together Intervention

Intervention Type BEHAVIORAL

Learning Skills Together is a 6-week psychoeducational intervention developed to improve caregivers' confidence when completing complex care tasks (e.g., using a gait belt). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to communicate with someone who is living with dementia, medication management, and home safety. Participants are also provided with a workbook that accompanies each lesson, and includes short readings, videos, additional resources, as well as weekly practice and reflection exercises.

Caregiver Healthy Living Intervention

Healthy living intervention for family caregivers

Group Type ACTIVE_COMPARATOR

Caregiver Healthy Living Intervention

Intervention Type BEHAVIORAL

Participants in the Caregiver Healthy Living Intervention will participate in a 6-week educational intervention to help improve caregiver health behaviors (e.g., getting enough sleep). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to eat a healthy diet, getting enough physical activity, and taking care of mental health. Participants are also provided a workbook that includes short readings and additional resources.

Interventions

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Learning Skills Together Intervention

Learning Skills Together is a 6-week psychoeducational intervention developed to improve caregivers' confidence when completing complex care tasks (e.g., using a gait belt). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to communicate with someone who is living with dementia, medication management, and home safety. Participants are also provided with a workbook that accompanies each lesson, and includes short readings, videos, additional resources, as well as weekly practice and reflection exercises.

Intervention Type BEHAVIORAL

Caregiver Healthy Living Intervention

Participants in the Caregiver Healthy Living Intervention will participate in a 6-week educational intervention to help improve caregiver health behaviors (e.g., getting enough sleep). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to eat a healthy diet, getting enough physical activity, and taking care of mental health. Participants are also provided a workbook that includes short readings and additional resources.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Is aged 18 years or older
* Be a family member, including "families of choice," to an individual living with Alzheimer's disease or a related dementia who has received a diagnosis from a physician
* Provide assistance with at least two instrumental activities of daily living or one activity of daily living
* Report a Global Deterioration Scale (GDS) rating for care recipients between 4 to 6
* Commit to attending at least 5 of the 6 discussion sessions
* Has reliable access to the internet and email and be able to attend synchronous sessions using the Zoom videoconferencing platform

Exclusion Criteria

* Unable to read and speak English
* Participated in Learning Skills Together in the past
* Plans to place the care recipient in a skilled nursing facility within the next 9 months (i.e., study duration)
* Was diagnosed with depression and/or started or significantly altered their depression treatment, including starting a pharmacological therapy or beginning therapy, in the previous 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Kylie Meyer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kylie N Meyer, PhD, Mac

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kylie N Meyer, PhD, MSc

Role: CONTACT

216-368-1928

Patricia N Burant, Ed.D., M.A.

Role: CONTACT

216-368-1928

Facility Contacts

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Kylie Meyer, PhD

Role: primary

References

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Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N, Fishman T, Falloon K, Hatcher S. Validation of PHQ-2 and PHQ-9 to screen for major depression in the primary care population. Ann Fam Med. 2010 Jul-Aug;8(4):348-53. doi: 10.1370/afm.1139.

Reference Type BACKGROUND
PMID: 20644190 (View on PubMed)

Gitlin LN, Winter L, Dennis MP, Corcoran M, Schinfeld S, Hauck WW. Strategies used by families to simplify tasks for individuals with Alzheimer's disease and related disorders: psychometric analysis of the Task Management Strategy Index (TMSI). Gerontologist. 2002 Feb;42(1):61-9. doi: 10.1093/geront/42.1.61.

Reference Type BACKGROUND
PMID: 11815700 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

McClendon MJ, Smyth KA. Quality of informal care for persons with dementia: dimensions and correlates. Aging Ment Health. 2013;17(8):1003-15. doi: 10.1080/13607863.2013.805400. Epub 2013 Jun 11.

Reference Type BACKGROUND
PMID: 24171485 (View on PubMed)

Meyer K, Glassner A, Norman R, James D, Sculley R, LealVasquez L, Hepburn K, Liu J, White C. Caregiver self-efficacy improves following complex care training: Results from the Learning Skills Together pilot study. Geriatr Nurs. 2022 May-Jun;45:147-152. doi: 10.1016/j.gerinurse.2022.03.013. Epub 2022 Apr 18.

Reference Type BACKGROUND
PMID: 35447558 (View on PubMed)

Ritter PL, Sheth K, Stewart AL, Gallagher-Thompson D, Lorig K. Development and Evaluation of the Eight-Item Caregiver Self-Efficacy Scale (CSES-8). Gerontologist. 2022 Mar 28;62(3):e140-e149. doi: 10.1093/geront/gnaa174.

Reference Type BACKGROUND
PMID: 33146727 (View on PubMed)

Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral problems in dementia: the revised memory and behavior problems checklist. Psychol Aging. 1992 Dec;7(4):622-31. doi: 10.1037//0882-7974.7.4.622.

Reference Type BACKGROUND
PMID: 1466831 (View on PubMed)

Zauszniewski JA. Resourcefulness. West J Nurs Res. 2016 Dec;38(12):1551-1553. doi: 10.1177/0193945916665079. No abstract available.

Reference Type BACKGROUND
PMID: 27794127 (View on PubMed)

Zauszniewski JA, Burant CJ. Resourcefulness as a Mediator of the Effects of Dementia Symptoms and Caregiver Reactions on Caregiver Mental Health. Issues Ment Health Nurs. 2020 Jun;41(6):486-493. doi: 10.1080/01612840.2019.1693670. Epub 2020 Apr 7.

Reference Type BACKGROUND
PMID: 32255406 (View on PubMed)

Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57.

Reference Type BACKGROUND
PMID: 16764178 (View on PubMed)

Meyer K, Lee K, Thorngthip S, Burant P, Lippe M, Neidre D, White C, Norman R, Choi BY, Glover CM, Bell J, Hepburn K. A randomised controlled trial of the Learning Skills Together (LST) intervention to improve dementia family caregivers' self-efficacy with complex care. Trials. 2024 Jun 8;25(1):369. doi: 10.1186/s13063-024-08204-8.

Reference Type DERIVED
PMID: 38851719 (View on PubMed)

Other Identifiers

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R01AG077554

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20220947

Identifier Type: -

Identifier Source: org_study_id

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