Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity

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.

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.

Study Overview

• Status: Completed
• Conditions: Multimorbidity
• Intervention / Treatment: Other: Care as usual; Other: Health and Life in Balance

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:

1. What were the characteristics of patients recruited to the pilot study? (QUAN),
2. What components were delivered in the HLB intervention? (QUAN)
3. Was the HLB intervention associated with improvements in the proposed primary and secondary outcomes? (QUAN)
4. How did patients and health care providers experience HLB regarding participant selection, intervention content and impact on health? (QUAL)
5. 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:

1. Baseline data including age, sex, and number and types of diagnoses and medications were collected from patient medical records

2. 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)

3. Clinical outcomes was collected from patients' medical records before, and after the intervention

   * Number of medications

4. 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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Nacka
    • Saltsjö-Boo, Nacka, Sweden, 132 30
      • Boo vårdcentral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 65 years and older
• 2 or more chronic diseases
• Increased care need defined by patient's GP

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Unit; 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.	Other: Health and Life in Balance; 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.
Placebo Comparator: Control Unit; 29 participating patients in the control unit. These patients had care as usual.	Other: Care as usual; Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: Caroline Wachtler, MD, PhD, Assistant Professor, Karolinska Institute and Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Multimorbidity; Person-centered care; Complex intervention
• Other Study ID Numbers: Dnr 2021-04267.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD collected throughout the trial will be shared in a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No