Learning Skills Together Family Caregiver Complex Intervention

NCT05846984 | Active Not Recruiting

• 2 other identifiers: STUDY20220947R01AG077554
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Caregiver Burden; Self Efficacy; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• Change in Caregiver Self-Efficacy

  Self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale (CSES-8; α=0.88 to 0.89; Ritter et al., 2020) Participants are asked to rate on a scale of 1 to 10 how confident they are with 8 aspects of caregiving (e.g., controlling upsetting thoughts). Scores range from 8 to 80, where higher scores indicate higher levels of caregiver self-efficacy. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention).

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

• Change in Caregiver Self-Efficacy with Complex Care (Author Generated)

  The investigators developed a caregiver complex care self-efficacy measure based upon discussions with healthcare faculty (Meyer et al., 2022). This 16-item scale asks about how confident caregivers feel with various complex care tasks (e.g., "Managing incontinence issues") and asks caregivers to rate their confidence from 0 ("Not at all confident") to 5 ("Very confident"). Pilot data showed high internal consistency (α=0.89). Higher scores indicate higher levels of self-efficacy with complex care tasks. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention).

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

• Change in Caregiver Self-Efficacy with Complex Care

  Self-efficacy with complex care will also be measured using the Caregiver Confidence in Sign/Symptom Management Scale (α=0.91), which subscales for Knowledge of Symptoms (α=0.56), Management of Cognitive Symptoms (α=0.82), Management of Medical Symptoms (α=0.78), and General Medical Management (α=0.94). Caregivers are asked how "true" statements are regarding their 1) knowledge, 2) ability to care for, and 3) make decisions about complex care tasks, as well as their level of confidence with various tasks. Scores range from 25 to 125, where higher scores indicate higher levels of caregiver self-efficacy with complex care. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention).

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

Secondary Outcomes (4)

• Change in Caregiver Resourcefulness

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

• Change in Caregiver Depressive Symptomology

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

• Appraisal of Behavioral Symptoms of Dementia

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

• Change in Quality of Care

  Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention)

Study Arms (2)

Learning Skills Together Intervention

EXPERIMENTAL

Complex care psychoeducation training intervention for family caregivers

Behavioral: Learning Skills Together Intervention

Caregiver Healthy Living Intervention

ACTIVE COMPARATOR

Healthy living intervention for family caregivers

Behavioral: Caregiver Healthy Living Intervention

Interventions

Learning Skills Together Intervention 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.

Learning Skills Together Intervention

Caregiver Healthy Living Intervention 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.

Caregiver Healthy Living Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (11)

• 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.

  PMID: 20644190 BACKGROUND

• 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.

  PMID: 11815700 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 24171485 BACKGROUND

• 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.

  PMID: 35447558 BACKGROUND

• 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.

  PMID: 33146727 BACKGROUND

• 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.

  PMID: 1466831 BACKGROUND

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

  PMID: 27794127 BACKGROUND

• 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.

  PMID: 32255406 BACKGROUND

• 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.

  PMID: 16764178 BACKGROUND

• 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.

  PMID: 38851719 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Kylie N Meyer, PhD, Mac

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: May 6, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified data will be deposited into NACDA repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication or public disclosure of a submitted patent application, whichever is earlier.
• Access Criteria: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes (e.g., cross-sectional analysis of baseline data). Novice users (e.g., doctoral students without advisor support) will have access to de-identified data and documentation regardless of level of experience or credentials. Sharing of analytic code will be provided at the discretion of the investigator team, based on the assessed qualification of the access requester, where "expert users" with an advanced academic degree or other relevant experience will be provided with code files.

Locations

US (1)