DementiaNCT02038192
Pilot Study of the Living With Hope Program for Family Caregivers of Persons With Dementia Residing in Long Term Care
A study testing Living with Hope Program and Stories of the Present in people with Dementia, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Living with Hope Program and Stories of the Present
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- English speaking
- Have a family member or friend with dementia who resides in Long Term Care.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Living With Hope: Pilot Study of the Living With Hope Program for Family Caregivers of Persons With Dementia Residing in Long Term Care Facilities
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
Read the detailed description
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
- Dementia
- Being tested
- Living with Hope Program, Stories of the Present
- Keywords
- Caregiver, Dementia, Long Term Care, Hope, Quality of Life, Intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living with Hope ProgramBehavioural
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 PresentBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Living with Hope Program | Experimental | 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. Receives: Behavioral: Living with Hope Program |
| Stories of the Present | Experimental | Participants in this group will write Stories of the Present and not see the film. Receives: Behavioral: Stories of the Present |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hope
Hope is measured by the Herth Hope Index (HHI). The Herth Hope Index is a 12 item (1-4 point)Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. The HHI has been found to take approximately 5 minutes to complete. Summative scores range from 12-48, with a higher score denoting greater hope. The HHI has been found to be reliable (test-retest r=91, p<0.05) and valid (concurrent validity, r=84, p.,0.05; criterion, r=92, p,0.05; divergent, r=-0.73, p,0.05).
Measured: Change from baseline at day 7, 14 and 28
Secondary outcomes (1)
Quality of Life
Quality of Life is measured by the World Health Organization Quality of Life -Bref measure. The WHOQOL-BREF is a quality of life assessment measure based on the World Health Organization definition of quality of life reflecting 4 domains of quality of life: physical health (Domain 1), psychological health (Domain 2), social relations (Domain 3), and environment (Domain 4). The WHOQOL-BREF is comprised of 26 items measuring the domains and is a shorter version of the original WHOQOL. The scores are not reported as a total, but per domain. The higher the score, the higher the subjects' reported quality of life in each domain. Reliability has been reported to be 0.82. Cronbach's alpha for this scale was r = 0.76.
Measured: Change from baseline at day 7, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy D. Duggleby, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038192
- Sponsor's protocol ID
- Pro00041954
- Status last verified
- Jan 2015
- First submitted
- 4 Oct 2013
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Hope: Pilot Study of the Living With Hope Program for Family Caregivers of Persons With Dementia Residing in Long Term Care Facilities
- ClinicalTrials.gov ID
- NCT02038192
- Acronym / sponsor ID
- Pro00041954
- Conditions
- Dementia
- Keywords
- Caregiver, Dementia, Long Term Care, Hope, Quality of Life, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Living with Hope Program | Experimental | Behavioral: Living with Hope ProgramAll 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. |
| Stories of the Present | Experimental | Behavioral: Stories of the PresentParticipants in this group will write Stories of the Present and not see the film. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- English speaking
- Have a family member or friend with dementia who resides in Long Term Care.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living with Hope ProgramThe 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. | Behavioural | Living with Hope Program |
| Stories of the PresentStories 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 | Behavioural | Stories of the Present |
Primary outcome
Hope
Time frame: Change from baseline at day 7, 14 and 28
Hope is measured by the Herth Hope Index (HHI). The Herth Hope Index is a 12 item (1-4 point)Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. The HHI has been found to take approximately 5 minutes to complete. Summative scores range from 12-48, with a higher score denoting greater hope. The HHI has been found to be reliable (test-retest r=91, p<0.05) and valid (concurrent validity, r=84, p.,0.05; criterion, r=92, p,0.05; divergent, r=-0.73, p,0.05).
1 secondary outcome
Quality of Life
Time frame: Change from baseline at day 7, 14 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy D. Duggleby, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living with Hope Program and Stories of the Present in people with Dementia, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hope (time frame: Change from baseline at day 7, 14 and 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.