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

NCT06791135 | Completed

• 1 other identifier: Dnr 2021-04267.
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multimorbidity

Keywords

Multimorbidity; Complex intervention; Person-centered care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Multimorbidty Treatment Burden Questionnaire

  From enrollment to the end of the treatment at 6 months.

• EQ-5D-5L - EuroQol -5 Dimensions- 5L

  From enrollment to the end of the treatment at 6 months.

• PHQ-9 - The Patient Health Questionnaire

  From enrollment to the end of the treatment at 6 months.

• PSWQ - The Penn State Worry Questionnaire

  From enrollment to the end of the treatment at 6 months.

• WHODAS 2.0 - WHO Disability Assessment Schedule

  From enrollment to the end of the treatment at 6 months.

Other Outcomes (7)

• Descriptive outcome - Number and types of follow-up visits

  Collected post-intervention (up to 1 year)

• Descriptive outcome - proportion of first visit(s) involving a follow-up booking

  Collected post-intervention (up to 1 year)

• Descriptive outcome - Number of first visit (s)

  Collected post-intervention (up to 1 year)

Study Arms (2)

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.

Other: Health and Life in Balance

Control Unit

PLACEBO COMPARATOR

29 participating patients in the control unit. These patients had care as usual.

Other: Care as usual

Interventions

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.

Intervention Unit

Care as usual OTHER

Care as usual

Control Unit

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Boo Vårdcentral

Saltsjö-Boo, Nacka, 132 30, Sweden

Location

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Caroline Wachtler, MD, PhD, Assistant Professor

  Karolinska Institute and Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Convergent Mixed-methods non-randomised pilot study

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 24, 2025
• Study Start: January 23, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

SE (1)