Socially Isolated Older Adults Living With Dementia
3. januar 2022 opdateret af: Hyun-Jun Kim, University of Washington
The lack of efficacious research-based interventions for sexual and gender minority (SGM) older adults living with Alzheimer's disease and other dementias, combined with the heightened risk of cognitive impairment in this population, presents a significant public health problem.
SGM older adults are at elevated risk of social isolation and experience significant barriers to healthcare access.
Existing interventions for older adults with dementia have been found to be effective for caregiving dyads.
Yet SGM older adults, compared to heterosexuals, are significantly less likely to be married or to have biological family members to support them.
A significant proportion of SGM older adults living with dementia have no caregiver or care network.
The goal of the proposed research is to design and pilot test the cultural appropriateness, acceptability, and feasibility of an innovative translation of a personalized care network-RDAD (Reducing Disability in Alzheimer's Disease) to support those living with dementia without a family caregiver, directly addressing unique SGM-specific risk factors.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We will address the following aims:
Aim 1. Develop a personalized care network-RDAD intervention suitable for SGM older adults living with dementia without caregivers.
Aim 2. Implement a preliminary randomized controlled trial (RCT) of 30 participants with 2 arms (routine medical care vs. the personalized care network-RDAD approach) to assess the acceptability, feasibility, and initial efficacy of the intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98195
- UWashington
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age at enrollment is 50 years of age or older
- Self-identify as LGBT (or sexual or gender non-binary or same sex sexual behavior)
- Have early stage dementia, including Alzheimer's disease or needs help with complex daily activities
- Living in the community, not in a care facility.
Exclusion Criteria:
- Known terminal illness (with death anticipated within the next 12 months)
- Hospitalization for a psychiatric disorder in the 12 months prior to baseline
- Have more than early stage dementia
- Any physical limitations/chronic conditions preventing participation in an exercise program.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Personalized care network
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
|
The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
|
Ingen indgriben: Routine medical care
No intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Physical Activity
Tidsramme: Baseline (pre-treatment) and 7 weeks (post-treatment)
|
Minutes spent on exercising per week in the past month were calculated from the following two questions: (1) How much time did you spend on exercises (hours per day) on a typical day during the last month; (2) How many days did you spend on exercises during the last month.
|
Baseline (pre-treatment) and 7 weeks (post-treatment)
|
|
Change in Physical Functioning
Tidsramme: Baseline (pre-treatment) and 7 weeks (post-treatment)
|
Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36) consists of 10 items and measures how much participants' health status limits their activities including walking, climbing, lifting, and bathing or dressing oneself, based on self-reports.
Each item is measured a 3-point scale (1 = Yes, limited a lot; 2 = Yes, limited a little; 3 = No, not limited at all), then recoded into 0, 50, and 100, respectively.
The recoded scores are averaged to generate a summary score with its possible range from 0 to 100.
Higher scores indicate better physical functioning.
|
Baseline (pre-treatment) and 7 weeks (post-treatment)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Quality of Life
Tidsramme: Baseline (pre-treatment) and 7 weeks (post-treatment)
|
Quality of Life in Alzheimer's Disease (QOL-AD) is a 13-item scale that measures participant's self-reported feelings about different aspects of life including energy, mood, living situation, memory, family, friends, ability, and money.
Each item has a 4-point response scale (1 = poor; 2 = fair; 3 = good; 4 = excellent).
The summary score is a sum of the 13 items with its possible range from 13 to 52.
Higher scores indicate higher quality of life.
|
Baseline (pre-treatment) and 7 weeks (post-treatment)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Hyun-Jun Kim, PhD, University of Washington
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. august 2020
Primær færdiggørelse (Faktiske)
30. december 2020
Studieafslutning (Faktiske)
30. december 2020
Datoer for studieregistrering
Først indsendt
7. september 2018
Først indsendt, der opfyldte QC-kriterier
7. september 2018
Først opslået (Faktiske)
12. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00005149
- 5P30AG034592-05 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .