DementiaDIF2NCT01287767
A Support Program for Carers of Persons With Dementia
A study testing A multidimensional support program in people with Dementia and Depression, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial summary
Dementia is one of the most common and devastating diseases in the elderly, it leads to helplessness, no cure exists and therefore care is necessary to provide. The care is associated with a great burden for the family carers and expensive for the society when residential care is required. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Depression
- What is being tested?
- A multidimensional support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2009to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Home dwelling patients and carers with at least weekly face-to face contact with the patients
- The patients should have a diagnosis of dementia according to ISD-10 criteria
- A Mini Mental State Examination (MMSE)og at least 15 point.
- Have capacity to give informant consent to participation in the study
- The carers should score at least five on the Relatives'Stress Scale(RSS)
Who cannot join
- Result from the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Support Program for Carers of Persons With Dementia - a 24 Months RCT
Dementia is one of the most common and devastating diseases in the elderly, it leads to helplessness, no cure exists and therefore care is necessary to provide. The care is associated with a great burden for the family carers and expensive for the society when residential care is required. The purpose of this study is to improve knowledge on how to provide better care for both the patients and their family carers, the investigators want to carry out a controlled trial using a rather cheap form of intervention, a multidimensional support program - an 18 months randomized controlled intervention study.
Read the detailed description
The 230 dyads of families, patients and carers, will be recruited from 18 municipalities, 18 from each municipality with at least 15 000 inhabitants. Only home dwelling patients and carers with at least weekly face-to face contact with the patient will be included. The patients will be recruited both from memory clinics, outpatients clinics in geriatric medicine and old age psychiatry and from home nurse districts. The patients should have a diagnosis of dementia according to ICD-10 criteria, have a score on Mini Mental State Examination of at least 15 points and have capacity to give informant consent to participation in the study. The carers should score at least five on the Relatives' Stress Scale.
115 family, control group, will receive care 'as usual' in the municipalities. The 115 family intervention group will have a duration of 18 months consisting individual counselling, education about dementia, problem-solving groups and ad-hoc counselling when needed. Effects will be measured at three levels, at patient level, at carer level and at societal level. Measurements will take place at baseline, after three, six, 12 and 18 months. At patient level, the Cornell scale will be used as the primary outcome. At carer's level, the primary outcome is the Relatives' Stress Scale. For the outcome on the social level Resource Utilisation in Dementia will be used.
The carers will be contacted every year up till five years after the intervention ended to give information about their own physical and psychological health and the patient's use of formal help such as day care centre, respite care and permanent nursing home placement.
- Conditions
- Dementia, Depression
- Being tested
- A multidimensional support program
- Keywords
- Dementia, Depression, Burden of care, Psychosocial intervention, Family home care
- Medical subject headings
- Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multidimensional support programBehavioural
Counseling, education and problem-solving in support group, ad hoc counseling
| Study group | Role | What they receive |
|---|---|---|
| Control group, ordinary support | No intervention | Home care as usual. |
| A multidimensjonalt support program | Experimental | •Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups. Receives: Behavioral: A multidimensional support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in level of depression between groups
Cornell scala for depression will be used to measure depression among the person with dementia and Geriatric Depression Scale (GDS) will be used for the carer.
Measured: After 12 months
Secondary outcomes (17)
Resource Utilisation in Dementia
Resource Utilisation in Dementia (RUD Lite) instrument (Wimo, 1998) which contains questions concerning use of community care services, type of accommodation, the employment status of the patient and primary caregiver, medical and informal care.
Measured: after 12 months
Change in stress among carers
Relatives Stress Scale(RSS) will be used
Measured: after 12 months
Neuropsychiatric Inventory (NPI)
Measured: after 12 months
Quality of life among people with dementia and carers
The Quality of life in Alzheimer's disease (QOL-AD)
Measured: after 12 months
Measures function in activities of daily living
Lawton \& Brody Instrumental and Performance activities daily living scale (IADL and PADL)
Measured: after 12 months
measure expressed emotion
Using Felt Expressed Emotion Rating Scale (FEERS)
Measured: after 12 months
Locus of control among carers
Measured: after 12 months
Mini mental status (MMSE)
Measured: after 12 months
Differences in level of depression between groups
Cornell scala for depression will be used to measure depression among the person with dementia and Geriatric Depression Scale (GDS) will be used for the carer.
Measured: after 24 months
Resource Utilisation in Dementia
Measured: after 24 months
Change in stress among carers(RSS)
Measured: after 24 months
Neuropsychiatric Inventory (NPI)
Measured: after 24 months
Quality of life among people with dementia and carers(QOL-AD)
Measured: after 24 months
Measures function in activities of daily living
Measured: after 24 months
Locus of control among carers
Measured: after 24 months
measure expressed emotion
Measured: after 24 months
Mini mental status (MMSE)
Measured: after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionJan 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Kavli Research Center for Ageing and Dementia
- Responsible party
- Sponsor
- Investigators
- Knut Engedal, M.D.PhD, Principal investigator, Norwegian Centre for Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287767
- Sponsor's protocol ID
- FI09
- Other IDs
- NFR189449
- Acronym
- DIF2
- Status last verified
- Oct 2015
- First submitted
- 26 Jan 2011
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjorge H, Kvaal K, Ulstein I. The effect of psychosocial support on caregivers' perceived criticism and emotional over-involvement of persons with dementia: an assessor-blinded randomized controlled trial. BMC Health Serv Res. 2019 Oct 24;19(1):744. doi: 10.1186/s12913-019-4551-x.
PubMed 31651321
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Support Program for Carers of Persons With Dementia - a 24 Months RCT
- ClinicalTrials.gov ID
- NCT01287767
- Acronym / sponsor ID
- DIF2 / FI09
- Conditions
- Dementia, Depression
- Keywords
- Dementia, Depression, Burden of care, Psychosocial intervention, Family home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Kavli Research Center for Ageing and Dementia
- Study start
- Oct 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Feb 2011 (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.
Dementia is one of the most common and devastating diseases in the elderly, it leads to helplessness, no cure exists and therefore care is necessary to provide. The care is associated with a great burden for the family carers and expensive for the society when residential care is required. The purpose of this study is to improve knowledge on how to provide better care for both the patients and their family carers, the investigators want to carry out a controlled trial using a rather cheap form of intervention, a multidimensional support program - an 18 months randomized controlled intervention study.
Detailed description
The 230 dyads of families, patients and carers, will be recruited from 18 municipalities, 18 from each municipality with at least 15 000 inhabitants. Only home dwelling patients and carers with at least weekly face-to face contact with the patient will be included. The patients will be recruited both from memory clinics, outpatients clinics in geriatric medicine and old age psychiatry and from home nurse districts. The patients should have a diagnosis of dementia according to ICD-10 criteria, have a score on Mini Mental State Examination of at least 15 points and have capacity to give informant consent to participation in the study. The carers should score at least five on the Relatives' Stress Scale.
115 family, control group, will receive care 'as usual' in the municipalities. The 115 family intervention group will have a duration of 18 months consisting individual counselling, education about dementia, problem-solving groups and ad-hoc counselling when needed. Effects will be measured at three levels, at patient level, at carer level and at societal level. Measurements will take place at baseline, after three, six, 12 and 18 months. At patient level, the Cornell scale will be used as the primary outcome. At carer's level, the primary outcome is the Relatives' Stress Scale. For the outcome on the social level Resource Utilisation in Dementia will be used.
The carers will be contacted every year up till five years after the intervention ended to give information about their own physical and psychological health and the patient's use of formal help such as day care centre, respite care and permanent nursing home placement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group, ordinary support | No intervention | –Home care as usual. |
| A multidimensjonalt support program | Experimental | Behavioral: A multidimensional support program•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Home dwelling patients and carers with at least weekly face-to face contact with the patients
- The patients should have a diagnosis of dementia according to ISD-10 criteria
- A Mini Mental State Examination (MMSE)og at least 15 point.
- Have capacity to give informant consent to participation in the study
- The carers should score at least five on the Relatives'Stress Scale(RSS)
Key exclusion criteria (1 listed)
- Result from the inclusion criteria
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 |
|---|---|---|
| A multidimensional support programCounseling, education and problem-solving in support group, ad hoc counseling | Behavioural | A multidimensjonalt support program |
Primary outcome
Differences in level of depression between groups
Time frame: After 12 months
Cornell scala for depression will be used to measure depression among the person with dementia and Geriatric Depression Scale (GDS) will be used for the carer.
17 secondary outcomes
Resource Utilisation in Dementia
Time frame: after 12 months
Change in stress among carers
Time frame: after 12 months
Neuropsychiatric Inventory (NPI)
Time frame: after 12 months
Quality of life among people with dementia and carers
Time frame: after 12 months
Measures function in activities of daily living
Time frame: after 12 months
measure expressed emotion
Time frame: after 12 months
Locus of control among carers
Time frame: after 12 months
Mini mental status (MMSE)
Time frame: after 12 months
Differences in level of depression between groups
Time frame: after 24 months
Resource Utilisation in Dementia
Time frame: after 24 months
Change in stress among carers(RSS)
Time frame: after 24 months
Neuropsychiatric Inventory (NPI)
Time frame: after 24 months
Quality of life among people with dementia and carers(QOL-AD)
Time frame: after 24 months
Measures function in activities of daily living
Time frame: after 24 months
Locus of control among carers
Time frame: after 24 months
measure expressed emotion
Time frame: after 24 months
Mini mental status (MMSE)
Time frame: after 24 months
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 7 Oct 2015.
- Derived from this study: PubMed 31651321Bjorge H, Kvaal K, Ulstein I. The effect of psychosocial support on caregivers' perceived criticism and emotional over-involvement of persons with dementia: an assessor-blinded randomized controlled trial. BMC Health Serv Res. 2019 Oct 24;19(1):744. doi: 10.1186/s12913-019-4551-x.
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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.
Knut Engedal, M.D.PhD principal investigator
Norwegian Centre for Ageing and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multidimensional support program in people with Dementia and Depression, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
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 5 inclusion and 1 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 7 Oct 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 Norway. 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?
Differences in level of depression between groups (time frame: After 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287767, which also lists 1 linked publication.
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 7 Oct 2015.