MultimorbidityNCT06791135
Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity
A study testing Health and Life in Balance and Care as usual in people with Multimorbidity, run by Region Stockholm at 1 site in Sweden.
Trial summary
The aim of this study was to examine if the intervention "Health and Life in Balance", was acceptable, feasible and if the intervention needed further development. Health and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Health and Life in Balance and Care as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2022to 31 May 2023
- 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
- 65 years and older
- 2 or more chronic diseases
- Increased care need defined by patient's GP
Who cannot join
- home health care,
- on-going treatment in a secondary unit making them unable to assimilate the intervention, for example ongoing oncological treatment,
- cognitive impairment that restricted ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity: A Pragmatic Mixed Methods Non-randomised Pilot Study
The aim of this study was to examine if the intervention "Health and Life in Balance", was acceptable, feasible and if the intervention needed further development.
Health and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. It involved for the patient to meet with a district nurse during 1-2 meetings to set up a care plan and then have scheduled follow-ups during 6 months. During the 1-2 meetings they went through ICAN discussion aid to discuss aspects of capacity and workload in the patient's life and healthcare. The district nurse and the patient's GP had improved communication during the intervention period.
Read more
Researchers will collect data from the patient's medical records, from questionnaires and from interviews with patients and health care providers.
Data will be analysed using both quantitative and qualitative methodologies and finally a mixed methods approach.
No drugs or devices are included in this study.
Read the detailed description
Patients with multimorbidity, having more than one chronic disease, becomes more and more common as the world's population ages. However, primary care, often focusing on treating one disease at a time in short visits, show poor results in meeting these patients' needs. Hence, primary care needs to become more person-centered to meet patients with multimorbidity's needs.
In this study Health and Life in Balance, a complex intervention to improve relational continuity, person centeredness, and teamwork between the patient's district nurse and GP was piloted. The aim of the intervention was to improve patients with multimorbidity's capacity.
The aim of this study was to assess acceptability, feasibilty and need of further development of the intervention.
The study design was convergent mixed methods non randomised pilot study.
The research questions were:
- What were the characteristics of patients recruited to the pilot study? (QUAN),
- What components were delivered in the HLB intervention? (QUAN)
- Was the HLB intervention associated with improvements in the proposed primary and secondary outcomes? (QUAN)
- How did patients and health care providers experience HLB regarding participant selection, intervention content and impact on health? (QUAL)
- What patients should HLB target and how should the intervention be delivered in a future trial? (MIXED)
Recruitment and setting:
In this study, 2 primary care units in Region Stockholm, Sweden were recruited. One was an intervention unit and the other a control unit. In both units patients 65 years and older with 2 or more chronic diseases and an increased care need were recruited by their GPs.
Intervention:
The intervention was conducted during 6 months and involved:
- Improved teamwork between the patient's GP and district nurse
- 1-2 visits with a district nurse. During the visit they went through the discussion aid ICAN. The discussion aid aims to assess patient capacity and workload from life and from health care contacts. And morst important Then they set up a care plan.
- Then they had individualised number and types of follow up contacts.
Patients in the intervention unit received the intervention and patients in the control unit received care as usual.
No drugs or devices are included in this study.
Data collection:
Quantitative data was collected in both units regarding:
- Baseline data including age, sex, and number and types of diagnoses and medications were collected from patient medical records
- In questionnaires by a research nurse in both units before and after the intervention. The questionnaires were:
- Illness intrusiveness: Illness Intrusiveness Rating Scale (IIRS)
- Treatment burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)
- Quality of Life: EuroQol -5 Dimensions- 5L (EQ-5D-5L)
- Depressive symptoms: The Patient Health Questionnaire (PHQ-9)
- Worry: The Penn State Worry Questionnaire (PSWQ)
- General health: WHO Disability Assessment Schedule (WHODAS 2.0)
- Alcohol consumption : The Alcohol Use Disorders Identification Test (AUDIT)
- Drug consumption The Drug Use Disorders Identification Test (DUDIT)
- Clinical outcomes was collected from patients' medical records before, and after the intervention
- Number of medications
- Clinical outcomes was collected from participants' medical records after the intervention was finished regarding
- Number of visits in primary care (apart from the intervention) during the intervention period.
- Number of visits in secondary care during the intervention period.
- Number of admissions to hospitals during the intervention period.
Quantitative data was collected from patient medical records in the intervention unit after the intervention was finished regarding:
- Number and types of visits (part of the intervention) during the intervention
- A written care plan
- A written description of GP and DN teamwork.
Qualitative data was collected from:
- Individual interviews with participating patients in the intervention unit
- Focus group interviews with district nurses in the middle and after the intervention period.
- Focus group interviews with GPs after the intervention concluded.
- Patient medical records in the intervention unit.
Data analysis:
Quantitative data analysis:
- Descriptive statistical analyses were used to assess baseline differences between both units.
- Statistical analyses were used to assess between group differences between intervention and control group after 6 months regarding questionnaires and number of medications.
Qualitative data analysis:
- Thematic analysis by Braun and Clark was used to qualitatively analyse all qualitative data.
Mixed methods data analysis:
Quantitative and qualitative data analyses were merged together to answer the mixed methods question using joint display on interpretation level.
- Conditions
- Multimorbidity
- Being tested
- Health and Life in Balance, Care as usual
- Keywords
- Multimorbidity, Complex intervention, Person-centered care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and Life in BalanceOther
Health and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. It involved for the patient to meet with a district nurse during 1-2 meetings to set up a care plan and then have scheduled follow-ups during 6 months. During the 1-2 meetings they went through ICAN discussion aid to discuss aspects of capacity and workload in the patient's life and healthcare. The district nurse and the patient's GP had improved communication during the intervention period.
No use of drugs or devices was part of the intervention.
Care as usualOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Intervention Unit | Experimental | 23 participating patients in the intervention unit. These patients had the intervention Health and Life in Balance during 6 months. The intervention did not include the use of drugs or devices. Receives: Other: Health and Life in Balance |
| Control Unit | Placebo comparator | 29 participating patients in the control unit. These patients had care as usual. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness Intrusivenss Rating Scale
13 items scored 1 - 7 to a total of 13 (not very intrusive) to 91 (very intrusive)
Measured: From enrollment to the end of the treatment at 6 months.
Secondary outcomes (10)
Multimorbidty Treatment Burden Questionnaire
10 items scored to a total of 0 (no burden) to 100 (>22 high burden)
Measured: From enrollment to the end of the treatment at 6 months.
EQ-5D-5L - EuroQol -5 Dimensions- 5L
A five-dimension index score with weights derived from the English population, total -0.59 to 1, (1 representing optimal health)
Measured: From enrollment to the end of the treatment at 6 months.
PHQ-9 - The Patient Health Questionnaire
9-items scored 0 to 3 to a total where <5 indicates absence of depressive disorder and ≥15 major depression
Measured: From enrollment to the end of the treatment at 6 months.
PSWQ - The Penn State Worry Questionnaire
16 items scored 1 to 5, 16 is the minimal level of worry and 80 the maximum
Measured: From enrollment to the end of the treatment at 6 months.
WHODAS 2.0 - WHO Disability Assessment Schedule
12 items scored 0 to 4, 0 points represents optimal health and 48 worst health
Measured: From enrollment to the end of the treatment at 6 months.
AUDIT - The Alcohol Use Disorders Identification Test, 12-item version
12 items scored 0 - 5 with a total ≤ 7 suggests low-risk; 8 - 14 hazardous; ≥ 15 alcohol dependence
Measured: From enrollment to the end of the treatment at 6 months.
DUDIT - The Drug Use Disorders Identification Test
11 items scored 0 to 4, a total score ≥25 suggests dependence
Measured: From enrollment to the end of the treatment at 6 months.
Number of medications
Medication count from electronic list
Measured: From enrollment to the end of the treatment at 6 months.
Number of visits in primary care (apart from the intervention)
Visit count from medical records
Measured: Collected post-intervention (up to 1 year)
Number of admissions to hospitals
Admission count from medical records
Measured: Collected post-intervention (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start23 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 May 2023
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 MultimorbidityStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Convergent Mixed-methods non-randomised pilot study
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Caroline Wachtler, MD, PhD, Assistant Professor, Principal investigator, Karolinska Institute and Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791135
- Sponsor's protocol ID
- Dnr 2021-04267.
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD collected throughout the trial will be shared in a publication
Publications
Kappelin C, Nordenskiold KY, Sparen EB, Lagerin A, Wachtler C. The Health and Life in Balance intervention to improve patient capacity for older people with multimorbidity: a pragmatic mixed methods non-randomised pilot study. BMC Prim Care. 2025 Sep 8;26(1):279. doi: 10.1186/s12875-025-02974-z.
PubMed 40922036
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity: A Pragmatic Mixed Methods Non-randomised Pilot Study
- ClinicalTrials.gov ID
- NCT06791135
- Acronym / sponsor ID
- Dnr 2021-04267.
- Conditions
- Multimorbidity
- Keywords
- Multimorbidity, Complex intervention, Person-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 24 Jan 2025 (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.
The aim of this study was to examine if the intervention "Health and Life in Balance", was acceptable, feasible and if the intervention needed further development.
Health and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. It involved for the patient to meet with a district nurse during 1-2 meetings to set up a care plan and then have scheduled follow-ups during 6 months. During the 1-2 meetings they went through ICAN discussion aid to discuss aspects of capacity and workload in the patient's life and healthcare. The district nurse and the patient's GP had improved communication during the intervention period.
Researchers will collect data from the patient's medical records, from questionnaires and from interviews with patients and health care providers.
Data will be analysed using both quantitative and qualitative methodologies and finally a mixed methods approach.
No drugs or devices are included in this study.
Detailed description
Patients with multimorbidity, having more than one chronic disease, becomes more and more common as the world's population ages. However, primary care, often focusing on treating one disease at a time in short visits, show poor results in meeting these patients' needs. Hence, primary care needs to become more person-centered to meet patients with multimorbidity's needs.
In this study Health and Life in Balance, a complex intervention to improve relational continuity, person centeredness, and teamwork between the patient's district nurse and GP was piloted. The aim of the intervention was to improve patients with multimorbidity's capacity.
The aim of this study was to assess acceptability, feasibilty and need of further development of the intervention.
The study design was convergent mixed methods non randomised pilot study.
The research questions were:
- What were the characteristics of patients recruited to the pilot study? (QUAN),
- What components were delivered in the HLB intervention? (QUAN)
- Was the HLB intervention associated with improvements in the proposed primary and secondary outcomes? (QUAN)
- How did patients and health care providers experience HLB regarding participant selection, intervention content and impact on health? (QUAL)
- What patients should HLB target and how should the intervention be delivered in a future trial? (MIXED)
Recruitment and setting:
In this study, 2 primary care units in Region Stockholm, Sweden were recruited. One was an intervention unit and the other a control unit. In both units patients 65 years and older with 2 or more chronic diseases and an increased care need were recruited by their GPs.
Intervention:
The intervention was conducted during 6 months and involved:
- Improved teamwork between the patient's GP and district nurse
- 1-2 visits with a district nurse. During the visit they went through the discussion aid ICAN. The discussion aid aims to assess patient capacity and workload from life and from health care contacts. And morst important Then they set up a care plan.
- Then they had individualised number and types of follow up contacts.
Patients in the intervention unit received the intervention and patients in the control unit received care as usual.
No drugs or devices are included in this study.
Data collection:
Quantitative data was collected in both units regarding:
- Baseline data including age, sex, and number and types of diagnoses and medications were collected from patient medical records
- In questionnaires by a research nurse in both units before and after the intervention. The questionnaires were:
- Illness intrusiveness: Illness Intrusiveness Rating Scale (IIRS)
- Treatment burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)
- Quality of Life: EuroQol -5 Dimensions- 5L (EQ-5D-5L)
- Depressive symptoms: The Patient Health Questionnaire (PHQ-9)
- Worry: The Penn State Worry Questionnaire (PSWQ)
- General health: WHO Disability Assessment Schedule (WHODAS 2.0)
- Alcohol consumption : The Alcohol Use Disorders Identification Test (AUDIT)
- Drug consumption The Drug Use Disorders Identification Test (DUDIT)
- Clinical outcomes was collected from patients' medical records before, and after the intervention
- Number of medications
- Clinical outcomes was collected from participants' medical records after the intervention was finished regarding
- Number of visits in primary care (apart from the intervention) during the intervention period.
- Number of visits in secondary care during the intervention period.
- Number of admissions to hospitals during the intervention period.
Quantitative data was collected from patient medical records in the intervention unit after the intervention was finished regarding:
- Number and types of visits (part of the intervention) during the intervention
- A written care plan
- A written description of GP and DN teamwork.
Qualitative data was collected from:
- Individual interviews with participating patients in the intervention unit
- Focus group interviews with district nurses in the middle and after the intervention period.
- Focus group interviews with GPs after the intervention concluded.
- Patient medical records in the intervention unit.
Data analysis:
Quantitative data analysis:
- Descriptive statistical analyses were used to assess baseline differences between both units.
- Statistical analyses were used to assess between group differences between intervention and control group after 6 months regarding questionnaires and number of medications.
Qualitative data analysis:
- Thematic analysis by Braun and Clark was used to qualitatively analyse all qualitative data.
Mixed methods data analysis:
Quantitative and qualitative data analyses were merged together to answer the mixed methods question using joint display on interpretation level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Convergent Mixed-methods non-randomised pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention Unit | Experimental | Other: Health and Life in Balance23 participating patients in the intervention unit. These patients had the intervention Health and Life in Balance during 6 months. The intervention did not include the use of drugs or devices. |
| Control Unit | Placebo comparator | Other: Care as usual29 participating patients in the control unit. These patients had care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years and older
- 2 or more chronic diseases
- Increased care need defined by patient's GP
Key exclusion criteria (3 listed)
- home health care,
- on-going treatment in a secondary unit making them unable to assimilate the intervention, for example ongoing oncological treatment,
- cognitive impairment that restricted ability to give informed consent.
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 |
|---|---|---|
| Health and Life in BalanceHealth and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. It involved for the patient to meet with a district nurse during 1-2 meetings to set up a care plan and then have scheduled follow-ups during 6 months. During the 1-2 meetings they went through ICAN discussion aid to discuss aspects of capacity and workload in the patient's life and healthcare. The district nurse and the patient's GP had improved communication during the intervention period. No use of drugs or devices was part of the intervention. | Other | Intervention Unit |
| Care as usualCare as usual | Other | Control Unit |
Primary outcome
Illness Intrusivenss Rating Scale
Time frame: From enrollment to the end of the treatment at 6 months.
13 items scored 1 - 7 to a total of 13 (not very intrusive) to 91 (very intrusive)
10 secondary outcomes
Multimorbidty Treatment Burden Questionnaire
Time frame: From enrollment to the end of the treatment at 6 months.
EQ-5D-5L - EuroQol -5 Dimensions- 5L
Time frame: From enrollment to the end of the treatment at 6 months.
PHQ-9 - The Patient Health Questionnaire
Time frame: From enrollment to the end of the treatment at 6 months.
PSWQ - The Penn State Worry Questionnaire
Time frame: From enrollment to the end of the treatment at 6 months.
WHODAS 2.0 - WHO Disability Assessment Schedule
Time frame: From enrollment to the end of the treatment at 6 months.
AUDIT - The Alcohol Use Disorders Identification Test, 12-item version
Time frame: From enrollment to the end of the treatment at 6 months.
DUDIT - The Drug Use Disorders Identification Test
Time frame: From enrollment to the end of the treatment at 6 months.
Number of medications
Time frame: From enrollment to the end of the treatment at 6 months.
Number of visits in primary care (apart from the intervention)
Time frame: Collected post-intervention (up to 1 year)
Number of admissions to hospitals
Time frame: Collected post-intervention (up to 1 year)
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 24 Jan 2025.
- Derived from this study: PubMed 40922036Kappelin C, Nordenskiold KY, Sparen EB, Lagerin A, Wachtler C. The Health and Life in Balance intervention to improve patient capacity for older people with multimorbidity: a pragmatic mixed methods non-randomised pilot study. BMC Prim Care. 2025 Sep 8;26(1):279. doi: 10.1186/s12875-025-02974-z.
- Individual participant dataSharing planned: Undecided. IPD collected throughout the trial will be shared in a publication
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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.
Caroline Wachtler, MD, PhD, Assistant Professor principal investigator
Karolinska Institute and Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and Life in Balance and Care as usual in people with Multimorbidity, run by Region Stockholm at 1 site in Sweden.
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 3 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 24 Jan 2025. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Illness Intrusivenss Rating Scale (time frame: From enrollment to the end of the treatment at 6 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 NCT06791135, 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 24 Jan 2025.