Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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:
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:
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
Quantitative data was collected from patient medical records in the intervention unit after the intervention was finished regarding:
Qualitative data was collected from:
Data analysis:
Quantitative data analysis:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Unit | Placebo Comparator | 29 participating patients in the control unit. These patients had care as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health and Life in Balance | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Illness Intrusivenss Rating Scale | 13 items scored 1 - 7 to a total of 13 (not very intrusive) to 91 (very intrusive) | From enrollment to the end of the treatment at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Multimorbidty Treatment Burden Questionnaire | 10 items scored to a total of 0 (no burden) to 100 (>22 high burden) | From enrollment to the end of the treatment at 6 months. |
| EQ-5D-5L - EuroQol -5 Dimensions- 5L |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive outcome - Number and types of follow-up visits | Number (n) of follow-up visits in A. the primary care unit B. In the patient's home C. By telephone during the intervention at the intervention unit. The outcome was collected from intervention participants' medical records. | Collected post-intervention (up to 1 year) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caroline Wachtler, MD, PhD, Assistant Professor | Karolinska Institute and Region Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boo Vårdcentral | Saltsjö-Boo | Nacka | 132 30 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40922036 | Derived | 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. |
Not provided
Not provided
IPD collected throughout the trial will be shared in a publication
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
Not provided
Not provided
Convergent Mixed-methods non-randomised pilot study
Not provided
Not provided
It is not possible to mask participating patients and health care providers. To avoid contamination we included one intervention and one control unit. In a potentially future RCT we aim to keep the cluster-design.
In a potential future trial we aim mask outcome assessors, and researchers handling data analyses.
Not provided
|
| Care as usual | Other | Care as usual |
|
A five-dimension index score with weights derived from the English population, total -0.59 to 1, (1 representing optimal health)
| 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 | 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 | 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 | 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 | 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 | From enrollment to the end of the treatment at 6 months. |
| Number of medications | Medication count from electronic list | 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 | Collected post-intervention (up to 1 year) |
| Number of admissions to hospitals | Admission count from medical records | Collected post-intervention (up to 1 year) |
| Descriptive outcome - proportion of first visit(s) involving a follow-up booking |
Proportion of 1-2 first visit (s) that involved follow-up booking. Data was collected from intervention participant's medical records. |
| Collected post-intervention (up to 1 year) |
| Descriptive outcome - Number of first visit (s) | Number (n) of first 1-2 visits ( 1 or 2). The outcome was collected from intervention participants' medical records. | Collected post-intervention (up to 1 year) |
| Descriptive outcome - proportion of first visit(s) involving a written care plan | Proportion of 1-2 first visit (s) that involved a written care plan. Data was collected from intervention participant's medical records. | Collected post-intervention (up to 1 year) |
| Descriptive outcome - ICAN used at the initial visit(s) | Was ICAN filled out a the first visit(s) yes or no. The outcome was collected from intervention participants' medical records. | Collected post-intervention (up to 1 year) |
| Descriptive outcome - Final visit offered and completed | Was a final visit offered and completed, yes or no. The outcome was collected from intervention participants' medical records. | Collected post-intervention (up to 1 year) |
| Descriptive outcome - Documented GP and DN teamwork | Number (n) of documented communication between DN and GP about intervention participants in the intervention unit during the intervention period. Data was collected from the intervention patients' medical records. | Collected post-intervention (up to 1 year) |