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Evaluation of "My Tools 4 Care" for Family Caregivers of Persons With Dementia

28 maggio 2017 aggiornato da: University of Alberta

Evaluation of a Transition Intervention for Family Caregivers of Persons With Alzheimer Disease and Multiple Chronic Conditions

With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing, supporting family care partners of persons with ADRD is critical. Family caregivers provide about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and multiple chronic conditions (MCC) experience significant, complex, distressing transitions such as changes to their environment, roles and relationships, physical and mental health, isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was developed for family caregivers of persons with ADRD and MCC living at home, to support caregivers through transitions and increase their self-efficacy, hope, and quality of life (QOL).

Through this pragmatic mixed methods randomized controlled trial the investigators expect to find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater improvement in hope, self-efficacy and QOL, at no additional cost from a societal perspective, compared with those in an educational control group. Following baseline data collection 180 participants will be randomly assigned to one of the groups with repeated measures at one, three and six months.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background: With the escalating numbers of persons with Alzheimer Disease and related dementias (ADRD) in Canada, the Rising Tide report suggests that supporting family care partners of persons with AD is critical. Family caregivers provide about 90% of in-home care for persons with ADRD. The care is often difficult and complex due to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and MCC experience significant, complex, distressing transitions such as changes to their environment, roles and relationships, physical and mental health, isolation, and taking on new tasks. A Transition Toolkit was developed for family caregivers of persons with AD living at home initially as a paper copy and since has been developed in an on-line format. The purpose of the Toolkit is to support caregivers through transitions and increase their self-efficacy, hope, and quality of life. Sections include About Me, Common Changes to Expect, Frequently Asked Questions, Resources, and Important Health Information. Data from a pilot study of the Toolkit suggest that it is feasible, acceptable, and may support caregivers through transitions. The on-line version of the Toolkit (My Tools 4 Care) includes interactive activities to help caregivers deal with their transitions and as such will be a novel online intervention. The investigators expect that "My Tools 4 Care" will result in improved caregiver outcomes, compared to an educational control group.

Research Questions: (1) Does a transition intervention (My Tools 4 Care) increase hope, self-efficacy and health related quality of life of caregivers of persons with AD and MCC compared with an educational control group from baseline, one month, 3 and 6 months? (2) What are the costs of use of health services at 3 and 6 months of the transition intervention compared with the control group, from a societal perspective? Methods: The design is a pragmatic, multisite, mixed-methods randomized controlled trial (Quantitative +qualitative) with family caregivers of persons >65 years of age who have ADRD and MCC. Participants will be English-speaking family or friends ≥ 18 years of age who provide physical, emotional, or financial care to persons with ADRD. Family caregivers will be recruited through multiple community associations, newspaper ads, posters, the Alberta Caregivers Association, the Alzheimer Society (AS) of Ontario and Alberta. Participants will be randomly assigned to:1) the on-line Transition toolkit (Group 1) or 2) an educational control group (Group 2) who will receive a copy of the Alzheimer's Society's The Progression of Alzheimer's Disease - Overview Booklet. The intervention group (Group 1) will receive instructions on how to access "My Tools 4 Care" for 3 months. To assess dosage of the intervention, caregivers will be asked to document their use of the intervention using a checklist. For the Educational Control Group (Group 2), the participants will receive a copy of the Booklet. Data for all participants will be collected at baseline, and again at 1 month, 3 and 6 months.

Outcome measures are a) hope [Herth Hope Index (HHI)] b) health related quality of life {Short Form 12 (SF-12v2)]) c) self-efficacy [General Self Efficacy Scale (GSES) which measures ability to deal with adverse situations]; and d) use and costs of health services [Health and Social Services Inventory (HSSUI)]. Trained data collectors will administer the instruments using audio-taped telephone interviews at baseline, 1, 3 and 6 months after the start of the intervention. A sample size of 180 caregivers (45 per group x 2 groups x 2 provinces) will provide 80% power (alpha = 0.05) to detect a mean difference of 2 increases in the HHI, GSES, and SF-12 v2, with a standard deviation of 2.5. At 3 months, all participants in group 1 will be interviewed using open-ended questions to further assess perceived effectiveness and mechanisms of change associated with the intervention.

Time Line: Recruitment and data collection will begin April 1, 2015 for 2 years (March 31, 2017). Analysis and report writing April 1, 2017-March 31, 2018.

Expected Outcomes: The investigators expect that family caregivers receiving the on-line Toolkit will show greater improvement in hope, self-efficacy and quality of life at no additional cost from a societal perspective, compared with those receiving the educational brochure.

Impact: The findings of the study will inform policy and practice as the Toolkit can be easily revised for local contexts and scalable in terms of posting on websites such as the Alzheimer Society.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

199

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • University of Alberta
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Jenny Ploeg

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Family caregivers of persons >65 years of age who have AD and related dementias (ADRD) and MCC (two or more chronic conditions)
  • English-speaking
  • Family or friends ≥ 18 years of age who provide physical, emotional, or financial care to persons with ADRD and MCC
  • Access and able to use a computer (and have an email address).

Exclusion Criteria:

Family caregivers caring for a person with ADRD and MCC who:

  • Has died
  • Resides in a Long Term Care Facility (nursing home)
  • Is hospitalized and designated as restorative care (Alberta) or alternate level of care (Ontario)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
The intervention group (Group 1) will receive instructions on how to access "My Tools 4 Care" for 3 months.
On-line self-administered (My Tools 4 Care) transition toolkit includes interactive activities and resources to help caregivers deal with their transitions
Nessun intervento: Educational Control
An educational control group (Group 2) will receive a copy of the Alzheimer's Society' The Progression of Alzheimer's Disease - Overview Booklet.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Health Related Quality of Life at One, Three and Six Months
Lasso di tempo: One, three and six months
SF 12v2 Mental Component and Physical Component Score
One, three and six months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Hope at One, Three and Six Months
Lasso di tempo: one, three and six months
Herth Hope Index
one, three and six months
Change from Baseline in General Self Efficacy at One, Three and Six Months
Lasso di tempo: One, three and six months
General Self-Efficacy Scale
One, three and six months

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2015

Completamento primario (Effettivo)

12 aprile 2017

Completamento dello studio (Effettivo)

12 aprile 2017

Date di iscrizione allo studio

Primo inviato

17 aprile 2015

Primo inviato che soddisfa i criteri di controllo qualità

22 aprile 2015

Primo Inserito (Stima)

28 aprile 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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