Pilot Study of the Living With Hope Program for Family Caregivers of Persons With Dementia Residing in Long Term Care

NCT ID: NCT02038192

Last Updated: 2015-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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Hope is important for family/friends of persons with dementia residing in Long Term Care Facilities. Our research team has developed a program (Living with Hope) to increase hope and quality of life of family caregivers. The Living with Hope Program involves a) viewing the Living with Hope film which features caregivers of persons with dementia describing their hope and b) a hope activity entitled "Stories of the Present". A new Living with Hope film entitled "Connecting with Hope" has been produced and will be used in this pilot study. The purpose of this pilot study is to evaluate the feasibility and acceptability of the Living With Hope Program and collect preliminary data on the effectiveness of the Living with Hope Program for family members of persons with dementia residing in Long Term Care.

30 participants will be recruited from St. Joseph's Auxiliary hospital, the Alzheimer's Society of Alberta, and the Alberta Caregivers Association in Edmonton based on inclusion criteria. Participants will be randomly assigned to one of three groups: treatment (Watching a film on hope and Stories of the Present for one month); low dose group (Stories of the Present only); or usual care group. In all groups measures of hope, quality of life, self-efficacy and guild will be collected at visit 1, day 7, day 14 and one month in addition to demographic information. Participants in group 1 and 2 (treatment group) will be asked to describe what they were thinking about when doing the hope activities on day 7, 14 and one month using qualitative interviews. At one month all participants will be interviewed using open ended audio-taped questions to help evaluate the study procedures

Detailed Description

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Background: Hope is important for family/friends of persons with dementia residing in Long Term Care Facilities (LTC). Our research team has developed a program (Living with Hope) to increase hope and quality of life of family caregivers. The Living with Hope Program (LWHP) involves a) viewing the Living with Hope film which features caregivers of persons with dementia describing their hope and b) a hope activity entitled "Stories of the Present". The hope activity consists of participants writing at the end of the day about their thoughts, challenges and what gave them hope over a 4- week time period. For family caregivers of persons with advanced cancer, this LWHP has been found to increase their hope and feelings of self-efficacy (confidence in their ability to deal with difficult situations). Based on a qualitative study of hope of family caregivers of persons with dementia residing in LTC, the LWHP has been adapted to that population. A new Living with Hope film entitled "Connecting with Hope" has been produced and will be used in this pilot study.

Aims: The purpose of this pilot study is to evaluate the feasibility and acceptability of the LWHP and collect preliminary data on the effectiveness of the Living with Hope Program for family members of persons with dementia residing in LTC.

Sample: Shannon Stachnik (Social Worker St. Joseph's Auxiliary Hospital), Arlene Huhn (Alzheimer's Society of Alberta - Edmonton) and Anna Mann (Alberta Caregivers Association) will identify potential participants based on the inclusion criteria. They will make contact and ask if the potential participants are willing to talk with a research nurse about the study. If they agree the research nurse will contact potential participants. Inclusion criterion for participants are: a) 18 years of age and older, b) English speaking, and c) have a family member or friend with dementia who resides in LTC.

The research nurse will contact potential participants and ask them when it will be a convenient time to meet with and obtain written informed consent.

Design: Using a mixed-methods randomized control trial (Quantitative +qualitative) design, 30 participants will be randomly assigned to one of three groups: 1) treatment (Watching a film on hope and Stories of the Present for one month), 2) low dose group (Stories of the Present only) or 3) usual care group. In all groups, demographic information, and baseline, day 7 ,14 and one month, measures of hope (Herth Hope Index), quality of life (WHOQOL-BREF), general self-efficacy (General Self-Efficacy Scale) and guilt (Caregiver Guilt Questionnaire) will be collected by a trained research nurse. Participants in group 1 and 2 (treatment group) will be asked to describe what they were thinking about when doing the hope activities on day 7, 14 and one month using qualitative interviews. At one month all participants will be interviewed using open ended audiotaped questions to help evaluate the study procedures

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Living with Hope Program

All participants in this group will receive the Living with Hope Program. It consists of viewing a 15 minute film on hope. Then for 5 minutes at the end of each day to write "Stories of the Present"to work on over one month. Stories of the present is a directed journaling activity which includes writing challenges of the day, what was their hope that day and what would be their hope tomorrow.

Group Type EXPERIMENTAL

Living with Hope Program

Intervention Type BEHAVIORAL

The Living with Hope Program is based on the research team's grounded theory study "Hope and Connection". The film " Connecting with Hope" reflects the findings of the grounded theory study. Stories of the Present has been utilized in the team's previous research with family caregivers of persons with advanced cancer.

Stories of the Present

Participants in this group will write Stories of the Present and not see the film.

Group Type EXPERIMENTAL

Stories of the Present

Intervention Type BEHAVIORAL

Stories of the Present is a directed journaling activity in which participants write in a journal at the end of the day their challenges, hope and hope for tomorrow

Usual Care

Participants in this group will not receive an intervention. Data collection for outcome variables will be the same as the participants in the other arms.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Living with Hope Program

The Living with Hope Program is based on the research team's grounded theory study "Hope and Connection". The film " Connecting with Hope" reflects the findings of the grounded theory study. Stories of the Present has been utilized in the team's previous research with family caregivers of persons with advanced cancer.

Intervention Type BEHAVIORAL

Stories of the Present

Stories of the Present is a directed journaling activity in which participants write in a journal at the end of the day their challenges, hope and hope for tomorrow

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* English speaking
* Have a family member or friend with dementia who resides in Long Term Care.

Exclusion Criteria

* persons who are non-autonomous adults
* cognitively impaired as determined by the Registered Nurse (RN) researcher
* unable to participate, in the opinion of the RN researcher
* non-English speaking
* does not have a family member or friend with dementia in Long Term Care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy D. Duggleby, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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Pro00041954

Identifier Type: -

Identifier Source: org_study_id

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