Healthy Older Adults Through Movement and Engagement

NCT07136168 | Recruiting

• 1 other identifier: 2024-04137-01
• Study Type: interventional
• Target: 2,952
• Locations: 1 country
• Sites: 1

Brief Summary

The HOME Project evaluates the effects of structured health dialogues with individuals aged 67-84 years in the municipality of Borgholm, Sweden. A combination of registry data and survey responses will be used to monitor quality of life, morbidity, healthcare needs, and lifestyle factors over a six-year period. Outcomes will be compared between randomized groups within Borgholm municipality and a matched control group from seven other municipalities in Region Kalmar. The project also includes an analysis of cost-effectiveness and the reach of the intervention. A qualitative interview study will explore participants' perceptions of their health, their motivations for health improvement, and their experiences of how the health dialogues may influence these aspects. In a substudy, machine learning models will be developed to predict functional decline and high healthcare needs among older adults. These models will be validated against established risk assessment tools such as the Adjusted Clinical Groups (ACG) system and the Charlson Comorbidity Index. Digital motion analysis using Skeleton Avatar Technology will be employed both independently and in combination with other variables to support model development.

Conditions

Frailty; Ageing Well; Prevention Intervention; Health Related Quality of Life

Keywords

health dialogue; frailty; cost-effectiveness; ageing well; primary care; health related quality of life

Outcome Measures

Primary Outcomes (2)

• Change in health-related quality of life

  EQ5D-5L (Euroqol 5 dimensions 5 levels) collected via postal questionnaire

  Baseline, at 16 months and 6 years from start of intervention

• Change in quality of life

  Quality of life measured by ICECAP-0 ( ICEpop CAPability measure for older people)

  Baseline, at 16 months and at 6 years from study start

Secondary Outcomes (12)

• Hospital care days

  16 months, 3 years and 6 years

• Hospital care episodes

  16 months, 3 years and 6 years

• Healthcare visits

  16 months, 3 years and 6 years from start of intervention

• Social care use

  16 months and 6 years from the start of the intervention

• Mortality

  16 months, 3 years and 6 years from start of intervention

Study Arms (2)

Health dialogue

EXPERIMENTAL

Participants will be invited to a health dialogue at primary health care center and to answer a questionnaire covering different aspects of health. Data from medical registers will be collected.

Behavioral: Health dialogue

Passive control

NO INTERVENTION

Participant will be invited to answer a questionnaire covering different aspects of health. Data from medical registers will be collected.

Interventions

Health dialogue BEHAVIORAL

1. Pre-visit 20 minutes including timed-up and go (TUG) walking test, length, weight, blood pressure, and blood tests ( HbA1C, PEth) 2. Structured health dialogue by a dedicated nurse practitioner for about 60 minutes covering living conditions, activity, everyday function, lifestyle habits and formation of a plan for improved health and referral to physician, physiotherapist or other primary care worker when appropriate 3. Follow-up call at 3 months with the nurse practitioner for evaluation and adjustment of the plan

Health dialogue

Eligibility Criteria

• Age: 67 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Living in Borgholm municipality or in one of 7 matched Demographical Statistical Area in Kalmar county
• Age between 67-84 years

You may not qualify if:

• Living in a nursing home
• Not speaking or understanding swedish language

Sponsors & Collaborators

• Linkoeping University: lead
• Linnaeus University: collaborator
• Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University.: collaborator
• Göteborg University: collaborator

Study Sites (1)

Hälsocentralen i Borgholm

Borgholm, County of Kalmar, SE - 58216, Sweden

RECRUITING

Related Publications (10)

• Proud L, McLoughlin C, Kinghorn P. ICECAP-O, the current state of play: a systematic review of studies reporting the psychometric properties and use of the instrument over the decade since its publication. Qual Life Res. 2019 Jun;28(6):1429-1439. doi: 10.1007/s11136-019-02114-y. Epub 2019 Jan 21.

  PMID: 30666550 BACKGROUND

• van Leeuwen KM, van Loon MS, van Nes FA, Bosmans JE, de Vet HCW, Ket JCF, Widdershoven GAM, Ostelo RWJG. What does quality of life mean to older adults? A thematic synthesis. PLoS One. 2019 Mar 8;14(3):e0213263. doi: 10.1371/journal.pone.0213263. eCollection 2019.

  PMID: 30849098 BACKGROUND

• Apostolo J, Cooke R, Bobrowicz-Campos E, Santana S, Marcucci M, Cano A, Vollenbroek-Hutten M, Germini F, D'Avanzo B, Gwyther H, Holland C. Effectiveness of interventions to prevent pre-frailty and frailty progression in older adults: a systematic review. JBI Database System Rev Implement Rep. 2018 Jan;16(1):140-232. doi: 10.11124/JBISRIR-2017-003382.

  PMID: 29324562 BACKGROUND

• Lincke A, Fagerstrom C, Ekstedt M, Lowe W, Backaberg S. A comparative study of the 2D- and 3D-based skeleton avatar technology for assessing physical activity and functioning among healthy older adults. Health Informatics J. 2023 Oct-Dec;29(4):14604582231214589. doi: 10.1177/14604582231214589.

  PMID: 37924210 BACKGROUND

• Klunder JH, Panneman SL, Wallace E, de Vries R, Joling KJ, Maarsingh OR, van Hout HPJ. Prediction models for the prediction of unplanned hospital admissions in community-dwelling older adults: A systematic review. PLoS One. 2022 Sep 23;17(9):e0275116. doi: 10.1371/journal.pone.0275116. eCollection 2022.

  PMID: 36149932 BACKGROUND

• Girwar SM, Jabroer R, Fiocco M, Sutch SP, Numans ME, Bruijnzeels MA. A systematic review of risk stratification tools internationally used in primary care settings. Health Sci Rep. 2021 Jul 23;4(3):e329. doi: 10.1002/hsr2.329. eCollection 2021 Sep.

  PMID: 34322601 BACKGROUND

• Bender AM, Jorgensen T, Pisinger C. Is self-selection the main driver of positive interpretations of general health checks? The Inter99 randomized trial. Prev Med. 2015 Dec;81:42-8. doi: 10.1016/j.ypmed.2015.07.004. Epub 2015 Jul 17.

  PMID: 26190370 BACKGROUND

• Nordstrom A, Bergman J, Bjork S, Carlberg B, Johansson J, Hult A, Nordstrom P. A multiple risk factor program is associated with decreased risk of cardiovascular disease in 70-year-olds: A cohort study from Sweden. PLoS Med. 2020 Jun 11;17(6):e1003135. doi: 10.1371/journal.pmed.1003135. eCollection 2020 Jun.

  PMID: 32525878 BACKGROUND

• Krogsboll LT, Jorgensen KJ, Gotzsche PC. General health checks in adults for reducing morbidity and mortality from disease. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD009009. doi: 10.1002/14651858.CD009009.pub3.

  PMID: 30699470 BACKGROUND

• Salomon JA, Wang H, Freeman MK, Vos T, Flaxman AD, Lopez AD, Murray CJ. Healthy life expectancy for 187 countries, 1990-2010: a systematic analysis for the Global Burden Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2144-62. doi: 10.1016/S0140-6736(12)61690-0.

  PMID: 23245606 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Adjunct senior lecturer

Model Details: Randomization of the selected population 1:2 to intervention ( health dialogue) or care as usual. Single site.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: October 7, 2025

Record last verified: 2025-08

Locations

SE (1)