FrailtyPRACTICNCT05651659
Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)
A study testing TIME model in the prevention and treatment of crises in frail community-dwelling people in people with Frailty, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC). Participatory action research in a cluster randomised controlled trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frailty
- What is being tested?
- TIME model in the prevention and treatment of crises in frail community-dwelling people
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 7 Jan 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- in need of home care services
- a score ≥5 on the Clinical Frailty Scale (indicating mild to severe frailty)
- perceived by the home care service as being in an unstable situation with a high risk for acute institutionalisation or showing resistance to care.
- being next of kin of a user of home care services who meets the above mentioned inclusion criteria
- regular contact with the patient (i.e., at least once a week).
Who cannot join
- expected short life expectancy (i.e., <4 weeks).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study
Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC). Participatory action research in a cluster randomised controlled trial. The primary purpose of this study is to test the effectiveness of an adapted version of a bio-psychosocial person centred model (TIME) to prevent and resolve crises for frail community-dwelling people receiving home care services. The investigators have formulated the following research questions (RQ):
RQ1: Can the TIME model adapted for home care service, prevent, and resolve crises in frail people receiving home care services? RQ2: Which participant characteristics or organizational factors are associated with the effect of the TIME model? RQ3: What are the experiences of the users of home care services on how crises were approached during the trial?
Read the detailed description
This study is part of the larger PRACTIC (Preventing and approaching crises for frail community-dwelling patients through innovative care) study. This is a six-month cluster randomized controlled trial (RCT). The trial will be conducted in 30 municipalities including 150 frail community-dwelling participants receiving homecare services judged by the services to have imminent crises. The proposed sample of 150 participants is based on a power calculation with clusters of approximately 5 participants from each of the 30 municipalities. Each municipality will be defined as a cluster and will be randomized to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures. For the interviews in RQ3, the investigators will use a purposeful sample of approximately 15 dyads with 15 patients and next of kin from the intervention municipalities in the RCT
Specially trained nurses (data assessors) from the project's research centre who are not affiliated with the municipalities will, together with staff members in the home care services, assess patients' baseline characteristics before randomisation. The data assessors will assess the effect of the intervention via telephone by interviewing the participants, the next of kin and the staff members who know the patient best, at three months and six months after baseline assessments. The interviews will based on a semi-structured interview guide where the participants will be asked to reflect on two main themes.
To evaluate the effects of a bio-psychosocial intervention like TIME to prevent and resolve crises in a heterogenous population, there is a need for a goal-oriented outcome compromising this variability. The goal of the intervention and the outcome will necessarily vary from patient to patient. The investigators will therefore use a individual goal-oriented interview, the PRACTIC goal-setting interview (PGI), based on The Bangor Goalsetting Interview, BGSI.
- Conditions
- Frailty
- Being tested
- TIME model in the prevention and treatment of crises in frail community-dwelling people
- Keywords
- frailty, crises, home care services, community-dwelling people, behavioural and psychological symptoms of dementia (BPSD), psychosocial interventions, case conferences
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIME model in the prevention and treatment of crises in frail community-dwelling peopleOther
TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically.
| Study group | Role | What they receive |
|---|---|---|
| Interventions municipalities | Experimental | Locally adapted TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) intervention. Municipalities will be randomly assigned to either the intervention group or the control group. A biostatician will perform the randomisation procedure independently of the project management team and the municipalities. The project management team will provide the home care services in the municipalities with the randomisation and allocation results immediately following this procedure. The intervention will start with the educational sessions (described below) within one to two weeks after randomisation. Receives: Other: TIME model in the prevention and treatment of crises in frail community-dwelling people |
| Control municipalities | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months
The primary outcome of the trial is the difference in the change between intervention and control group in individual goal achievement to resolve or reduce the challenges of the crises.
Measured: Change from baseline at 3 months using the PGI (scale of 1-10)
Secondary outcomes (17)
Change in PGI (PRACTIC Goal-setting Interview)
the differences in the change between intervention and control group in the BGSI scale at 6 months, in neuropsychiatric symptoms
Measured: at 6 moths
Change in symptoms (NPS)
Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144.
Measured: at 3 months
Change in symptoms (NPS)
Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144
Measured: at 6 months
Change in quality of life measured
Quality of life measured by the Quality of Life in Late Stage Dementia scale (QUALID). The score will remain between 11 and 55, with 11 representing the highest quality of life.
Measured: at 3 months
Change in quality of life measured
Quality of life measured by the Quality of Life in Late Stage Dementia scale (QUALID).The score will remain between 11 and 55, with 11 representing the highest quality of life.
Measured: at 6 moths
Change in distress perceived by the next of kin
Distress perceived by the next of kin measured by the Relative Stress Scale (RSS). Total score between 0-60, higher score in an area, more likely higher relative stress.
Measured: at 3 months
Change in distress perceived by the next of kin
Distress perceived by the next of kin measured by the Relative Stress Scale (RSS). Total score between 0-60, higher score in an area, more likely higher relative stress.
Measured: at 6 months
Change in rejection of care
Rejection of care - Minimal Data Set (MDS)
Measured: at 3 months
Change in rejection of care
Rejection of care - Minimal Data Set (MDS)
Measured: at 6 months
Change at Activities of Daily Living
Activities of Daily Living - assessed with the Physical Self-Maintenance Scale (PSMS). Total score between 0-30, higher score in an area, more likely that the patient may be in need of help in that area.
Measured: at 3 months
Change at Activities of Daily Living
Activities of Daily Living - assessed with the Physical Self-Maintenance Scale (PSMS).
Total score between 0-30, higher score in an area, more likely that the patient may be in need of help in that area.
Measured: at 6 months
Change in medication from medical records
Medication from medical records
Measured: at 3 months
Change in medication from medical records
Medication from medical records
Measured: at 6 months
Institutionalization
Change in level of care
Measured: at 3 months
Institutionalization
Change in level of care
Measured: at 6 months
Clinical Frailty scale
Frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
Measured: 6 months
EQ-5D questionnaire
The EQ-5D questionnaire to evaluate pain and discomfort. The dimension pain/discomfort has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement.
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 posted15 Dec 2022
- Study start7 Jan 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Norwegian National Advisory Unit on Ageing and Health, Helse Stavanger HF, Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany
- Responsible party
- Sponsor
- Investigators
- Sverre Bergh, MD. PhD, Study director, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651659
- Sponsor's protocol ID
- 150667
- Acronym
- PRACTIC
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collaborating partners in the study will not have access to the individual participant data. The data collected in the study are not publicly available. De-identified participant data will be made available upon reasonable request to the members of the research team at the Research Centre for Age-related Functional Decline and Disease (AFS), Innlandet Hospital Trust.
Publications
Vaeringstad A, Kirkevold O, Dalbak ETG, Myhre J, Feiring IH, Bergh S, Lichtwarck B. Development of the PRACTIC Goal Setting Interview (PGSI) for Frail Community-Dwelling Patients. Feasibility, Interrater Reliability and Content validity-a Mixed Methods Study. Patient Prefer Adherence. 2025 Dec 12;19:4033-4050. doi: 10.2147/PPA.S557233. eCollection 2025.
PubMed 41424838Dalbak ETG, Vaeringstad A, Lichtwarck B, Myhre J, Holle D, Bergh S, Kirkevold O. Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC): study protocol for a process evaluation of a complex intervention in home care service. Trials. 2025 May 28;26(1):178. doi: 10.1186/s13063-025-08876-w.
PubMed 40437640Vaeringstad A, Dalbak ETG, Holle D, Myhre J, Kirkevold O, Bergh S, Lichtwarck B. PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial. Trials. 2024 May 6;25(1):304. doi: 10.1186/s13063-024-08117-6.
PubMed 38711048
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study
- ClinicalTrials.gov ID
- NCT05651659
- Acronym / sponsor ID
- PRACTIC / 150667
- Conditions
- Frailty
- Keywords
- frailty, crises, home care services, community-dwelling people, behavioural and psychological symptoms of dementia (BPSD), psychosocial interventions, case conferences
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Norwegian National Advisory Unit on Ageing and Health, Helse Stavanger HF, Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 15 Dec 2022 (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.
Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC). Participatory action research in a cluster randomised controlled trial. The primary purpose of this study is to test the effectiveness of an adapted version of a bio-psychosocial person centred model (TIME) to prevent and resolve crises for frail community-dwelling people receiving home care services. The investigators have formulated the following research questions (RQ):
RQ1: Can the TIME model adapted for home care service, prevent, and resolve crises in frail people receiving home care services? RQ2: Which participant characteristics or organizational factors are associated with the effect of the TIME model? RQ3: What are the experiences of the users of home care services on how crises were approached during the trial?
Detailed description
This study is part of the larger PRACTIC (Preventing and approaching crises for frail community-dwelling patients through innovative care) study. This is a six-month cluster randomized controlled trial (RCT). The trial will be conducted in 30 municipalities including 150 frail community-dwelling participants receiving homecare services judged by the services to have imminent crises. The proposed sample of 150 participants is based on a power calculation with clusters of approximately 5 participants from each of the 30 municipalities. Each municipality will be defined as a cluster and will be randomized to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures. For the interviews in RQ3, the investigators will use a purposeful sample of approximately 15 dyads with 15 patients and next of kin from the intervention municipalities in the RCT
Specially trained nurses (data assessors) from the project's research centre who are not affiliated with the municipalities will, together with staff members in the home care services, assess patients' baseline characteristics before randomisation. The data assessors will assess the effect of the intervention via telephone by interviewing the participants, the next of kin and the staff members who know the patient best, at three months and six months after baseline assessments. The interviews will based on a semi-structured interview guide where the participants will be asked to reflect on two main themes.
To evaluate the effects of a bio-psychosocial intervention like TIME to prevent and resolve crises in a heterogenous population, there is a need for a goal-oriented outcome compromising this variability. The goal of the intervention and the outcome will necessarily vary from patient to patient. The investigators will therefore use a individual goal-oriented interview, the PRACTIC goal-setting interview (PGI), based on The Bangor Goalsetting Interview, BGSI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities
| Arm | Type | Receives |
|---|---|---|
| Interventions municipalities | Experimental | Other: TIME model in the prevention and treatment of crises in frail community-dwelling peopleLocally adapted TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) intervention. Municipalities will be randomly assigned to either the intervention group or the control group. A biostatician will perform the randomisation procedure independently of the project management team and the municipalities. The project management team will provide the home care services in the municipalities with the randomisation and allocation results immediately following this procedure. The intervention will start with the educational sessions (described below) within one to two weeks after randomisation. |
| Control municipalities | No intervention | –Care as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- in need of home care services
- a score ≥5 on the Clinical Frailty Scale (indicating mild to severe frailty)
- perceived by the home care service as being in an unstable situation with a high risk for acute institutionalisation or showing resistance to care.
- being next of kin of a user of home care services who meets the above mentioned inclusion criteria
- regular contact with the patient (i.e., at least once a week).
Key exclusion criteria (1 listed)
- expected short life expectancy (i.e., <4 weeks).
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 |
|---|---|---|
| TIME model in the prevention and treatment of crises in frail community-dwelling peopleTIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically. | Other | Interventions municipalities |
Primary outcome
Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months
Time frame: Change from baseline at 3 months using the PGI (scale of 1-10)
The primary outcome of the trial is the difference in the change between intervention and control group in individual goal achievement to resolve or reduce the challenges of the crises.
17 secondary outcomes
Change in PGI (PRACTIC Goal-setting Interview)
Time frame: at 6 moths
Change in symptoms (NPS)
Time frame: at 3 months
Change in symptoms (NPS)
Time frame: at 6 months
Change in quality of life measured
Time frame: at 3 months
Change in quality of life measured
Time frame: at 6 moths
Change in distress perceived by the next of kin
Time frame: at 3 months
Change in distress perceived by the next of kin
Time frame: at 6 months
Change in rejection of care
Time frame: at 3 months
Change in rejection of care
Time frame: at 6 months
Change at Activities of Daily Living
Time frame: at 3 months
Change at Activities of Daily Living
Time frame: at 6 months
Change in medication from medical records
Time frame: at 3 months
Change in medication from medical records
Time frame: at 6 months
Institutionalization
Time frame: at 3 months
Institutionalization
Time frame: at 6 months
Clinical Frailty scale
Time frame: 6 months
EQ-5D questionnaire
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41424838Vaeringstad A, Kirkevold O, Dalbak ETG, Myhre J, Feiring IH, Bergh S, Lichtwarck B. Development of the PRACTIC Goal Setting Interview (PGSI) for Frail Community-Dwelling Patients. Feasibility, Interrater Reliability and Content validity-a Mixed Methods Study. Patient Prefer Adherence. 2025 Dec 12;19:4033-4050. doi: 10.2147/PPA.S557233. eCollection 2025.
- Derived from this study: PubMed 40437640Dalbak ETG, Vaeringstad A, Lichtwarck B, Myhre J, Holle D, Bergh S, Kirkevold O. Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC): study protocol for a process evaluation of a complex intervention in home care service. Trials. 2025 May 28;26(1):178. doi: 10.1186/s13063-025-08876-w.
- Derived from this study: PubMed 38711048Vaeringstad A, Dalbak ETG, Holle D, Myhre J, Kirkevold O, Bergh S, Lichtwarck B. PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial. Trials. 2024 May 6;25(1):304. doi: 10.1186/s13063-024-08117-6.
- Individual participant dataSharing planned: Yes. Collaborating partners in the study will not have access to the individual participant data. The data collected in the study are not publicly available. De-identified participant data will be made available upon reasonable request to the members of the research team at the Research Centre for Age-related Functional Decline and Disease (AFS), Innlandet Hospital Trust.
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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, MD. PhD study director
Sykehuset Innlandet HF
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 model in the prevention and treatment of crises in frail community-dwelling people in people with Frailty, 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 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months (time frame: Change from baseline at 3 months using the PGI (scale of 1-10)). 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 NCT05651659, which also lists 3 linked publications.
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 4 May 2026.