DementiaNCT04034680
Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services
A study testing TIME and Education-only intervention in people with Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) is a multi-component intervention with a biopsychosocial approach, based on… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- TIME and Education-only intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2019to 30 Jun 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Dementia, defined as a score of 1 or more on the Clinical Dementia Rating Scale (CDR)
- A minimum of 15 minutes of home care services per day for the last 4 weeks
- NPS, defined as a score on the NPI-NH affective subsyndrom (NPI depression + NPI anxiety) of 12 or more
- Informed consent from the participant or family or next-of-kin
Who cannot join
- Terminal disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust
Ottestad, 2312
About this study
Official title: The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
Continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. The trial is designed to assess the effects of TIME on Neuropsychiatric symptoms for persons (NPS) with dementia in home care services.
Read the detailed description
The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. TIME consists of a manual based multicomponent program which includes a rigorous assessment, treatment, and the evaluation of neuropsychiatrc symptoms (NPS).
The cluster RCT will contain two parallel groups, where randomisation is performed based on clusters. One municipality is one cluster, randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. Totally 10 municipalities will be included. Data will be collected at baseline before randomisation and at the end of the implementing phase. Measurements at patient level are taken at baseline prior to randomization and after 6 months. The primary outcome measure is difference in change between the intervention group and the control group from baseline to follow up at 6 months in the Cornell Scale for Depression in Dementia (CSDD).
Data collection will be performed by project nurses recruited outside the home care services. They will interview the staff or family members who knows the patient best. The assessors will be blinded to the randomization of the home care services. Interviews will be done by telephone or face-to-face, depending on what is best for the person interviewed.
After the intervention focus group interviews with staff and family members will be conducted.
- Conditions
- Dementia
- Being tested
- TIME, Education-only intervention
- Keywords
- Behavioral symptoms, Dementia, Nevropsychiatric symptoms, Psychological symptoms, The TIME model
- Medical subject headings
- Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIMEOther
The intervention of the TIME model includes two hours of lectures about dementia and NPS and three hours of training and roleplay in using TIME. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational materials. From each municipality, three staff members called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention.
Education-only interventionOther
Staff in the home care service in municipalities in the control group will receive thesame two hours lectures about dementia and NPS as the intervention grorp. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities.
| Study group | Role | What they receive |
|---|---|---|
| Home care services - Intervention group | Experimental | Totally 5 municipalities (25 persons with dementia) will be included in the intervention group, and will receive training in the TIME model. This includes two hours of lectures about dementia and neuropsychiatric symptoms (NPS) and three hours of training and roleplay in using the TIME model. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational and information files. From each municipality, three staff members, called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention. Receives: Other: TIME |
| Home care services - Control group | Active comparator | Totally 5 municipalities (25 persons with dementia) will be included in the Control group. The municipalities in the control group will receive the same two hours lectures about dementia and NPS as the intervention group. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities. Receives: Other: Education-only intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
The change from baseline of affective symptoms as defined in the Cornell Scale for Depression in Dementia (CSDD), a scale ranging from 0-38 where a higher score indicates more severe depressive symptoms.
Measured: 6 months
Secondary outcomes (7)
Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression
The change from baseline in the sub syndrome affective symptoms of the single items anxiety and depression as measured with the NPI-NH. Each single item is scored from 0-12, where a higher score indicates a more severe symptom.
Measured: 6 months
NPI-NH: all separate items
The change from baseline of the NPI-NH, scores on all the 12 items. Each single item is scored from 0-12, where a higher score indicates a more severe symptom.
Measured: 6 months
NPI-NH: caregiver distress score
The change from baseline in caregiver distress by the NPI-NH caregiver distress score. The caregiver distress on each NPI-NH item is scored from 0-5, where a higher score indicates more severe distress
Measured: 6 months
Quality of life measured by the scale QUALID
The change from baseline in quality of life by whitch will be assessed by the scale QUALID: Quality of life in late-stage dementia scale, a scale consisting of 11 single items scored from 1-5 (total score 11-55) where a lower score indicates a better QoL.
Measured: 6 months
Change in Relatives Stress scale Score (RSS)
The change in relatives stress assessed by the scale RSS: Relatives Stress scale Score, a scale ranging from 0-60 where a higher score indicates more severe distress
Measured: 6 months
Transferring to nursing home
To measure the number of patients transferring to nursing home during follow up.
Measured: 12 months
Minimal data set (MDS): patient rejection of care
The change in the patients rejection of care assessed by MDS: Minimal dataset (MDS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Feb 2019
- Primary completion15 Jun 2020
- Study completion30 Jun 2020
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sverre Bergh, PhD, Principal investigator, The Research centre for Age-related Functional decline and Disease (AFS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034680
- Sponsor's protocol ID
- SI0303150608
- Status last verified
- Sep 2020
- First submitted
- 24 Jul 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
- ClinicalTrials.gov ID
- NCT04034680
- Acronym / sponsor ID
- SI0303150608
- Conditions
- Dementia
- Keywords
- Behavioral symptoms, Dementia, Nevropsychiatric symptoms, Psychological symptoms, The TIME model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Jul 2019 (actual)
- 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.
Continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. The trial is designed to assess the effects of TIME on Neuropsychiatric symptoms for persons (NPS) with dementia in home care services.
Detailed description
The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. TIME consists of a manual based multicomponent program which includes a rigorous assessment, treatment, and the evaluation of neuropsychiatrc symptoms (NPS).
The cluster RCT will contain two parallel groups, where randomisation is performed based on clusters. One municipality is one cluster, randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. Totally 10 municipalities will be included. Data will be collected at baseline before randomisation and at the end of the implementing phase. Measurements at patient level are taken at baseline prior to randomization and after 6 months. The primary outcome measure is difference in change between the intervention group and the control group from baseline to follow up at 6 months in the Cornell Scale for Depression in Dementia (CSDD).
Data collection will be performed by project nurses recruited outside the home care services. They will interview the staff or family members who knows the patient best. The assessors will be blinded to the randomization of the home care services. Interviews will be done by telephone or face-to-face, depending on what is best for the person interviewed.
After the intervention focus group interviews with staff and family members will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Home care services - Intervention group | Experimental | Other: TIMETotally 5 municipalities (25 persons with dementia) will be included in the intervention group, and will receive training in the TIME model. This includes two hours of lectures about dementia and neuropsychiatric symptoms (NPS) and three hours of training and roleplay in using the TIME model. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational and information files. From each municipality, three staff members, called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention. |
| Home care services - Control group | Active comparator | Other: Education-only interventionTotally 5 municipalities (25 persons with dementia) will be included in the Control group. The municipalities in the control group will receive the same two hours lectures about dementia and NPS as the intervention group. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Dementia, defined as a score of 1 or more on the Clinical Dementia Rating Scale (CDR)
- A minimum of 15 minutes of home care services per day for the last 4 weeks
- NPS, defined as a score on the NPI-NH affective subsyndrom (NPI depression + NPI anxiety) of 12 or more
- Informed consent from the participant or family or next-of-kin
Key exclusion criteria (1 listed)
- Terminal disease
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 |
|---|---|---|
| TIMEThe intervention of the TIME model includes two hours of lectures about dementia and NPS and three hours of training and roleplay in using TIME. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational materials. From each municipality, three staff members called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention. | Other | Home care services - Intervention group |
| Education-only interventionStaff in the home care service in municipalities in the control group will receive thesame two hours lectures about dementia and NPS as the intervention grorp. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities. | Other | Home care services - Control group |
Primary outcome
Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
Time frame: 6 months
The change from baseline of affective symptoms as defined in the Cornell Scale for Depression in Dementia (CSDD), a scale ranging from 0-38 where a higher score indicates more severe depressive symptoms.
7 secondary outcomes
Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression
Time frame: 6 months
NPI-NH: all separate items
Time frame: 6 months
NPI-NH: caregiver distress score
Time frame: 6 months
Quality of life measured by the scale QUALID
Time frame: 6 months
Change in Relatives Stress scale Score (RSS)
Time frame: 6 months
Transferring to nursing home
Time frame: 12 months
Minimal data set (MDS): patient rejection of care
Time frame: 6 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 29 Sep 2020.
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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.
Sverre Bergh, PhD principal investigator
The Research centre for Age-related Functional decline and Disease (AFS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIME and Education-only intervention in people with Dementia, run by Sykehuset Innlandet HF 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 4 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 29 Sep 2020. 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?
Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD) (time frame: 6 months). 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 29 Sep 2020.