Trial Outcomes & Findings for Experiencing Loss and Planning Ahead Study (NCT NCT03332979)
NCT ID: NCT03332979
Last Updated: 2020-10-19
Results Overview
Marwit-Meuser Caregiver Grief Inventory Short Form (MMCGI-SF) (Marwit and Meuser 2005). 18 items with a score range from 18-90. Higher scores indicate higher levels of grief from carers of people with dementia.
COMPLETED
150 participants
Baseline
2020-10-19
Participant Flow
11/01/2018-31/01/2019 Carers were recruited via a number of avenues including; 9 NHS hospital trusts across England who acted as Participant Identification Centres, the Join Dementia Research (JDR) website and through Alzheimer's Society avenues such as the Alzheimer's Society research network and the Care and Cure magazine.
Participant milestones
| Measure |
All Study Participants
All Study Participants/Usual care
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Experiencing Loss and Planning Ahead Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White British
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White Other
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed race- White and Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian/Asian British - Indian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian/Asian British - Pakistani
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Declined to answer
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
150 participants
n=5 Participants
|
|
Marital status
Single
|
17 Participants
n=5 Participants
|
|
Marital status
Married/cohabitating
|
124 Participants
n=5 Participants
|
|
Marital status
Divorced/separated
|
8 Participants
n=5 Participants
|
|
Marital status
Widowed
|
1 Participants
n=5 Participants
|
|
Relationship to person with dementia
Spouse/partner
|
70 Participants
n=5 Participants
|
|
Relationship to person with dementia
Adult child
|
72 Participants
n=5 Participants
|
|
Relationship to person with dementia
Other
|
8 Participants
n=5 Participants
|
|
Rurality
Urban Major Conurbation
|
70 Participants
n=5 Participants
|
|
Rurality
Urban City and Town
|
61 Participants
n=5 Participants
|
|
Rurality
Urban City and Town in a sparse setting
|
1 Participants
n=5 Participants
|
|
Rurality
Rural Town and Fringe
|
9 Participants
n=5 Participants
|
|
Rurality
Rural Village
|
5 Participants
n=5 Participants
|
|
Rurality
Rural Hamlets and Isolated Dwellings
|
3 Participants
n=5 Participants
|
|
Rurality
Missing
|
1 Participants
n=5 Participants
|
|
Deprivation
1
|
5 Participants
n=5 Participants
|
|
Deprivation
2
|
9 Participants
n=5 Participants
|
|
Deprivation
3
|
9 Participants
n=5 Participants
|
|
Deprivation
4
|
17 Participants
n=5 Participants
|
|
Deprivation
5
|
15 Participants
n=5 Participants
|
|
Deprivation
6
|
11 Participants
n=5 Participants
|
|
Deprivation
7
|
15 Participants
n=5 Participants
|
|
Deprivation
8
|
17 Participants
n=5 Participants
|
|
Deprivation
9
|
22 Participants
n=5 Participants
|
|
Deprivation
10
|
29 Participants
n=5 Participants
|
|
Deprivation
Missing
|
1 Participants
n=5 Participants
|
|
Employment status
Yes
|
98 Participants
n=5 Participants
|
|
Employment status
No
|
52 Participants
n=5 Participants
|
|
Support provided by carer
Emotional support
|
147 Participants
n=5 Participants
|
|
Support provided by carer
ADLs
|
54 Participants
n=5 Participants
|
|
Support provided by carer
IADL
|
144 Participants
n=5 Participants
|
|
Support provided by carer
Supervision
|
114 Participants
n=5 Participants
|
|
Years of education
|
16.2 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Person with dementia gender
Male
|
82 Participants
n=5 Participants
|
|
Person with dementia gender
Female
|
68 Participants
n=5 Participants
|
|
Person with dementia age
|
80.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Does the person with dementia require constant supervision
Yes
|
70 Participants
n=5 Participants
|
|
Does the person with dementia require constant supervision
No
|
70 Participants
n=5 Participants
|
|
Does the person with dementia require constant supervision
Other
|
9 Participants
n=5 Participants
|
|
Does the person with dementia require constant supervision
Missing
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineMarwit-Meuser Caregiver Grief Inventory Short Form (MMCGI-SF) (Marwit and Meuser 2005). 18 items with a score range from 18-90. Higher scores indicate higher levels of grief from carers of people with dementia.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Pre-death Grief in Dementia Caregiving
|
57.6 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: BaselineDementia Knowledge Assessment Scale (Annear, Toye et al. 2015). Possible score range 0-50 with a higher score indicating better knowledge of dementia.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Knowledge of How Dementia Progresses
|
34.8 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: BaselineTwo categorical questions will be used: 'Have you had discussions with the person with dementia regarding their wishes at the end of life? (yes/no). Do you feel you have a good understanding of their wishes for end of life care? (yes/not sure/no).
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Knowledge of the Person With Dementia's End of Life Preferences
Yes
|
110 Participants
|
|
Knowledge of the Person With Dementia's End of Life Preferences
Not sure
|
29 Participants
|
|
Knowledge of the Person With Dementia's End of Life Preferences
No
|
11 Participants
|
SECONDARY outcome
Timeframe: BaselineBinary variable - either have or do not have any form of advance plan (such as Power of Attorney, Advance decisions to refuse treatment, Do Not attempt Resuscitation, Advance Care plan) in place for the person with dementia.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Advance Decisions in Place for Person With Dementia
Not sure
|
8 Participants
|
|
Advance Decisions in Place for Person With Dementia
No
|
79 Participants
|
|
Advance Decisions in Place for Person With Dementia
Yes
|
63 Participants
|
SECONDARY outcome
Timeframe: BaselineHealth Literacy Questionnaire (Osborne et al. 2013) Subscale 1 'Feeling understood and supported by healthcare providers' a Average score of 4 items leading to a range of 1-4 with higher scores indicating areas of strength.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Communication With Healthcare Providers
|
2.7 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselineHealth Literacy Questionnaire (Osborne, Batterham et al. 2013) Sub-scale examines satisfaction with support for health from social network. Score is calculated as an average of the 5 items of the subscale leading to a score range of 1-4 with higher scores indicating that a person's social system provides them with all the support they want or need.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Social Support for Health Subscale of the Health Literacy Questionnaire
|
2.7 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: BaselineCarer report of their relative/friend's severity of dementia using the Clinical Dementia Rating scale (Morris 1993). This scale leads to scores 5 possible scores; 0=no dementia, 0.5=questionable dementia, 1=mild dementia, 2=moderate dementia and 3=severe dementia.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Dementia Severity
Severe dementia
|
48 Participants
|
|
Dementia Severity
Questionable dementia
|
4 Participants
|
|
Dementia Severity
Mild dementia
|
34 Participants
|
|
Dementia Severity
Moderate dementia
|
64 Participants
|
SECONDARY outcome
Timeframe: BaselineDuke University Religion Index (Koenig and Büssing 2010). Using the subscale 'Intrinsic religiosity' which assesses degree of personal religious commitment or motivation which has been more strongly associated with protecting from psychological distress. Possible score range is 0-12 with a higher score indicating a stronger personal religious commitment/motivation.
Outcome measures
| Measure |
All Study Participants
n=150 Participants
All Study Participants/Usual care
|
|---|---|
|
Intrinsic Religiosity
|
6.6 score on a scale
Standard Deviation 4.3
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Kirsten Moore
Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place