Clinical trial NCT05846984: Learning Skills Together Family Caregiver Complex Intervention
Official title: Learning Skills Together: A Randomized Controlled Trial of a Complex Care Skills Intervention to Improve AD/ADRD Caregiver Self-Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Caregiver Burden
Self Efficacy
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Caregiver Self-Efficacy
timeFrame: 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)
measure: Change in Caregiver Self-Efficacy with Complex Care (Author Generated)
timeFrame: 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)
measure: Change in Caregiver Self-Efficacy with Complex Care
timeFrame: 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:
measure: Change in Caregiver Resourcefulness
timeFrame: 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)
measure: Change in Caregiver Depressive Symptomology
timeFrame: 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)
measure: Appraisal of Behavioral Symptoms of Dementia
timeFrame: 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)
measure: Change in Quality of Care
timeFrame: 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)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Kylie N Meyer, PhD, Mac
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Zauszniewski JA. Resourcefulness. West J Nurs Res. 2016 Dec;38(12):1551-1553. doi: 10.1177/0193945916665079. No abstract available.
citation: 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.
citation: 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.