Frail Elderly PersonsNCT00877058

SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation

A study testing preventive home visit and senior meetings in people with Frail Elderly Persons, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 80 years and older
Conditions the study is for: Frail Elderly Persons
What is being tested?: preventive home visit and senior meetings
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 459 participants
Where: 1 siteSweden
Study dates: Jan 2008to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

80 years of age or older living in the community.
The participants should live in their ordinary housing
Independent on formal support
Independent on informal support
Cognitive intact defined as a Mini Mental Test score > 25

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Gothenburg University
Gothenburg, 416 56

Other trials in Sweden

About this study

Official title: Elderly Persons at the Risk Zone - a Randomized Controlled Trial of a Community Based Preventive Multiprofessional Program for Old Persons at Risk of Frailty

The present study "Elderly person in the risk zone" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www. Vardalinstitutet.net) which comprises research into three interventions. A fundamental principle in the research programme is that it comprises interventions addressing frail elderly person in different phases of the disablement process, from elderly persons who are beginning to develop frailty to very frail elderly persons receiving palliative care in the final period of their lives. The interventions also address the different requirements that arise with regard to professional contributions during the various phases of the ageing and disease process, ranging from health promotion to a need for an increasing degree of medical care, nursing, special care and rehabilitation, and finally, efforts that promote symptom relief, quality of life, security and satisfaction with care during the final period of life. The intervention "Elderly persons in the risk zone" addresses elderly persons that are on the point of developing frailty ("pre-frail") and are beginning to feel that they are being hindered from taking part in everyday activities. The hypothesis is that if an intervention is made when the persons are not so frail, it is possible to prevent/delay deterioration.

Can a health-promoting and preventive intervention for "prefrail" elderly persons:

prevent frailty, activity limitations and morbidity,
be a supportive factor in the social and physical environment,
affect life satisfaction
have an impact on the consumption of care
be cost-effective?

How do the frail elderly persons experience the intervention and its importance to health?

Conditions: Frail Elderly Persons
Being tested: preventive home visit, senior meetings
Keywords: Frailty, health promotion, prevention, self management, intervention
Medical subject headings: Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

preventive home visitBehavioural
senior meetingsBehavioural

Study groups in NCT00877058
Study group	Role	What they receive
1.Preventive home visit	Experimental	Preventive home visits: This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours. Receives: Behavioral: preventive home visit
2. Senior meetings	Experimental	The senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. Receives: Behavioral: senior meetings
3. Control group	No intervention	The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.

What is being measured

The primary outcome is the main question the study is designed to answer.

Dependence in Two or More Activities of Daily Living (ADL)
ADL stair case:
Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed
Measured: 1 year
Number of Partipants Measured Frail at 1-year Follow up
Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition
Measured: 1 year
Self Rated Health
Self rated health was measured by the question "In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008May 2011

First posted7 Apr 2009 (estimated)
Study startJan 2008
Primary completionFeb 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Frail Elderly PersonsStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00877058
Sponsor's protocol ID: G213 194/08
Status last verified: Jun 2014
First submitted: 6 Apr 2009
Last updated: 15 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ostby RH, Dahlin-Ivanoff S, Najar J, Lood Q. Health-promotion can sustain leisure participation among persons 80 years and older: results from the randomised controlled trial elderly persons in the risk zone. BMC Geriatr. 2026 Apr 1;26(1):489. doi: 10.1186/s12877-026-07401-1.
PubMed 41917822
Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568
Dahlin-Ivanoff S, Eklund K, Wilhelmson K, Behm L, Haggblom-Kronlof G, Ziden L, Landahl S, Gustafsson S. For whom is a health-promoting intervention effective? Predictive factors for performing activities of daily living independently. BMC Geriatr. 2016 Oct 6;16(1):171. doi: 10.1186/s12877-016-0345-8.
PubMed 27716095
Dahlin-Ivanoff S, Gosman-Hedstrom G, Edberg AK, Wilhelmson K, Eklund K, Duner A, Ziden L, Welmer AK, Landahl S. Elderly persons in the risk zone. Design of a multidimensional, health-promoting, randomised three-armed controlled trial for "prefrail" people of 80+ years living at home. BMC Geriatr. 2010 May 26;10:27. doi: 10.1186/1471-2318-10-27.
PubMed 20504358

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
Frailty, Pre-Frailty
RecruitingObservational study
High Intensity Interval Training Versus Moderate Intensity Continuous Training in Frail Elderly
Frail Elderly
Active, not recruiting
Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)
Frailty
Not yet recruitingObservational study
Communication for Early Mobilisation of People Living With Dementia Following Surgery for Hip Fracture
Dementia, Hip Fracture
RecruitingObservational study
Qualitative Study Exploring the Determinants Involved in the Management of Osteoporosis in Frail Elderly People
Osteoporosis

All Frail Elderly Persons trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Elderly Persons at the Risk Zone - a Randomized Controlled Trial of a Community Based Preventive Multiprofessional Program for Old Persons at Risk of Frailty
ClinicalTrials.gov ID: NCT00877058
Acronym / sponsor ID: G213 194/08
Conditions: Frail Elderly Persons
Keywords: Frailty, health promotion, prevention, self management, intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
Study start: Jan 2008
Primary completion: Feb 2011 (actual)
Study completion: May 2011 (actual)
First posted: 7 Apr 2009 (estimated)
Results: Posted 15 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Can a health-promoting and preventive intervention for "prefrail" elderly persons:

prevent frailty, activity limitations and morbidity,
be a supportive factor in the social and physical environment,
affect life satisfaction
have an impact on the consumption of care
be cost-effective?

How do the frail elderly persons experience the intervention and its importance to health?

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
1.Preventive home visit	Experimental	Behavioral: preventive home visitPreventive home visits: This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
2. Senior meetings	Experimental	Behavioral: senior meetingsThe senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging.
3. Control group	No intervention	–The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.

Who may qualify

Ages: 80 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

80 years of age or older living in the community.
The participants should live in their ordinary housing
Independent on formal support
Independent on informal support
Cognitive intact defined as a Mini Mental Test score > 25

Key exclusion criteria (0 listed)

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
preventive home visit	Behavioural	1.Preventive home visit
senior meetings	Behavioural	2. Senior meetings

Primary outcome

Dependence in Two or More Activities of Daily Living (ADL)
Time frame: 1 year
ADL stair case: Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed
Number of Partipants Measured Frail at 1-year Follow up
Time frame: 1 year
Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition
Self Rated Health
Time frame: 1 year
Self rated health was measured by the question "In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed

Results and safety

Results posted to the registry on 15 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Preventive Home Visits	174	137
2 Senior Meetings	171	131
3 Control Group	114	75

Primary outcome: Dependence in Two or More Activities of Daily Living (ADL)

Time frame: 1 year. Number. Unit: participants

Measure	1 Preventive Home Visits n = 174	2 Senior Meetings n = 171	3 Control Group n = 114
Value	35	26	44

2 Senior Meetings vs 3 Control Group: Odds Ratio (OR): 0.27 (95% CI 0.15 to 0.48), p <0.05, Chi-squared
1 Preventive Home Visits vs 3 Control Group: Odds Ratio (OR): 0.40 (0.05% CI 0.24 to 0.68), p = 0.001, Chi-squared

Primary outcome: Number of Partipants Measured Frail at 1-year Follow up

Time frame: 1 year. Number. Unit: participants

Measure	1 Preventive Home Visits n = 174	2 Senior Meetings n = 171	3 Control Group n = 114
Value	80	85	43

2 Senior Meetings vs 3 Control Group: Odds Ratio (OR): 1.56 (95% CI 0.96 to 2.52), p <0.05, Chi-squared
1 Preventive Home Visits vs 3 Control Group: Odds Ratio (OR): 1.28 (95% CI 0.79 to 2.08), p <0.05, Chi-squared

Population analysed: ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.

Primary outcome: Self Rated Health

Time frame: 1 year. Number. Unit: participants

Measure	1 Preventive Home Visits n = 174	2 Senior Meetings n = 171	3 Control Group n = 114
Value	31	29	31

2 Senior Meetings vs 3 Control Group: Odds Ratio (OR): 0.55 (95% CI 0.31 to 0.97), p <0.05, Chi-squared
1 Preventive Home Visits vs 3 Control Group: Odds Ratio (OR): 0.58 (95% CI 0.33 to 1.02), p <0.05, Chi-squared

Population analysed: ITT

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Preventive Home Visits	0 of 174 (0%)	0 of 174 (0%)	Not reported
2 Senior Meetings	0 of 171 (0%)	0 of 171 (0%)	Not reported
3 Control Group	0 of 114 (0%)	0 of 114 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41917822Ostby RH, Dahlin-Ivanoff S, Najar J, Lood Q. Health-promotion can sustain leisure participation among persons 80 years and older: results from the randomised controlled trial elderly persons in the risk zone. BMC Geriatr. 2026 Apr 1;26(1):489. doi: 10.1186/s12877-026-07401-1.
Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
Derived from this study: PubMed 27716095Dahlin-Ivanoff S, Eklund K, Wilhelmson K, Behm L, Haggblom-Kronlof G, Ziden L, Landahl S, Gustafsson S. For whom is a health-promoting intervention effective? Predictive factors for performing activities of daily living independently. BMC Geriatr. 2016 Oct 6;16(1):171. doi: 10.1186/s12877-016-0345-8.
Derived from this study: PubMed 20504358Dahlin-Ivanoff S, Gosman-Hedstrom G, Edberg AK, Wilhelmson K, Eklund K, Duner A, Ziden L, Welmer AK, Landahl S. Elderly persons in the risk zone. Design of a multidimensional, health-promoting, randomised three-armed controlled trial for "prefrail" people of 80+ years living at home. BMC Geriatr. 2010 May 26;10:27. doi: 10.1186/1471-2318-10-27.

Related trials for Frail Elderly Persons

Not yet recruiting
In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
Frailty, Pre-Frailty
RecruitingObservational study
High Intensity Interval Training Versus Moderate Intensity Continuous Training in Frail Elderly
Frail Elderly
Active, not recruiting
Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)
Frailty
Not yet recruitingObservational study
Communication for Early Mobilisation of People Living With Dementia Following Surgery for Hip Fracture
Dementia, Hip Fracture
RecruitingObservational study
Qualitative Study Exploring the Determinants Involved in the Management of Osteoporosis in Frail Elderly People
Osteoporosis

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.

Synneve Dahlin Ivanoff, Professor principal investigator

Göteborg University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing preventive home visit and senior meetings in people with Frail Elderly Persons, run by Vardalinstitutet The Swedish Institute for Health Sciences 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 5 inclusion and 0 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 15 Jul 2014. 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. 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?

Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dependence in Two or More Activities of Daily Living (ADL) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT00877058, which also lists 4 linked publications.

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 15 Jul 2014.