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

2017년 5월 28일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

199

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Health Related Quality of Life at One, Three and Six Months
기간: One, three and six months
SF 12v2 Mental Component and Physical Component Score
One, three and six months

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Hope at One, Three and Six Months
기간: 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
기간: One, three and six months
General Self-Efficacy Scale
One, three and six months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 4월 1일

기본 완료 (실제)

2017년 4월 12일

연구 완료 (실제)

2017년 4월 12일

연구 등록 날짜

최초 제출

2015년 4월 17일

QC 기준을 충족하는 최초 제출

2015년 4월 22일

처음 게시됨 (추정)

2015년 4월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 5월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 5월 28일

마지막으로 확인됨

2017년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

백치에 대한 임상 시험

My Tools 4 Care에 대한 임상 시험

구독하다