MultimorbidityPREFERNCT01577134
Personal Resources of Elderly People With Multimorbidity
A study testing Social-cognitive resource intervention in people with Multimorbidity, run by German Centre of Gerontology at 1 site in Germany.
Trial summary
PREFER II aims at developing psychological targeted theory- and evidence-based intervention components, which support older people with multiple illnesses in performing more physical activity. Many studies provide evidence for the importance of physical activity as a central mediator of health. Read more about this study
- Who is it for?
- Ages 64 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Social-cognitive resource intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 64 years or older
- community-residing
Who cannot join
- regularly exercising
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personal Resources of Elderly People With Multimorbidity: Fortification of Effective Health Behaviour
PREFER II aims at developing psychological targeted theory- and evidence-based intervention components, which support older people with multiple illnesses in performing more physical activity. Many studies provide evidence for the importance of physical activity as a central mediator of health. This means that determinants of physical activity such as personal resources constitute an ideal target for interventions.
Within PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning and self-monitoring will be targeted in the interventions. These factors are important both for motivating older people with multiple illnesses to change their health behaviors and to translate such motivation into behavior.
- Conditions
- Multimorbidity
- Being tested
- Social-cognitive resource intervention, no intervention
- Keywords
- multimorbidity, autonomy, older adults, physical activity, intervention, behavior change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social-cognitive resource interventionBehavioural
Intervention group that receives a behavior change technique intervention to increase volitional strategies and physical activity.
Social-cognitive resource interventionBehavioural
Active control group that receives a behavior change technique intervention to increase volitional strategies and volunteering.
no interventionBehavioural
Passive control group that receives no intervention until the 8.5 months follow-up. Subsequently, they receive the information by mail the active groups received within the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention to enhance physical activity | Experimental | Participants in this arm have high motivation to be regularly physically active. Face-to-face group intervention includes behavior change techniques to enhance physical activity. Receives: Behavioral: Social-cognitive resource intervention |
| Active control intervention | Active comparator | Face-to-face group intervention includes behavior change techniques to enhance volunteering and improve attitudes towards volunteering. Receives: Behavioral: Social-cognitive resource intervention |
| Passive control intervention | Other | Waiting-list control group, who receives all information (that the active groups got) via mail after completion of 8.5 months follow-up. Receives: Behavioral: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Measured: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months
Secondary outcomes (2)
Change in quality of Life
Measured: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months
Change in self-reported perceived autonomy
Measured: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Centre of Gerontology
- Sponsor type
- Other government
- Collaborators
- German Federal Ministry of Education and Research, Freie Universität Berlin
- Responsible party
- Sponsor
- Investigators
- Clemens Tesch-Römer, Prof. Dr., Study chair, German Centre of GerontologyRalf Schwarzer, Prof. Dr., Study chair, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577134
- Sponsor's protocol ID
- 01ET1001B
- Acronym
- PREFER
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2012
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Resources of Elderly People With Multimorbidity: Fortification of Effective Health Behaviour
- ClinicalTrials.gov ID
- NCT01577134
- Acronym / sponsor ID
- PREFER / 01ET1001B
- Conditions
- Multimorbidity
- Keywords
- multimorbidity, autonomy, older adults, physical activity, intervention, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- German Centre of GerontologyOther government
- Collaborators
- German Federal Ministry of Education and Research, Freie Universität Berlin
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PREFER II aims at developing psychological targeted theory- and evidence-based intervention components, which support older people with multiple illnesses in performing more physical activity. Many studies provide evidence for the importance of physical activity as a central mediator of health. This means that determinants of physical activity such as personal resources constitute an ideal target for interventions.
Within PREFER II, particularly positive views on ageing, attitudes, self-efficacy, planning and self-monitoring will be targeted in the interventions. These factors are important both for motivating older people with multiple illnesses to change their health behaviors and to translate such motivation into behavior.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention to enhance physical activity | Experimental | Behavioral: Social-cognitive resource interventionParticipants in this arm have high motivation to be regularly physically active. Face-to-face group intervention includes behavior change techniques to enhance physical activity. |
| Active control intervention | Active comparator | Behavioral: Social-cognitive resource interventionFace-to-face group intervention includes behavior change techniques to enhance volunteering and improve attitudes towards volunteering. |
| Passive control intervention | Other | Behavioral: no interventionWaiting-list control group, who receives all information (that the active groups got) via mail after completion of 8.5 months follow-up. |
Who may qualify
- Ages
- 64 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 64 years or older
- community-residing
Key exclusion criteria (1 listed)
- regularly exercising
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 |
|---|---|---|
| Social-cognitive resource interventionIntervention group that receives a behavior change technique intervention to increase volitional strategies and physical activity. | Behavioural | Intervention to enhance physical activity |
| Social-cognitive resource interventionActive control group that receives a behavior change technique intervention to increase volitional strategies and volunteering. | Behavioural | Active control intervention |
| no interventionPassive control group that receives no intervention until the 8.5 months follow-up. Subsequently, they receive the information by mail the active groups received within the intervention. | Behavioural | Passive control intervention |
Primary outcome
Change in physical activity
Time frame: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months
2 secondary outcomes
Change in quality of Life
Time frame: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months
Change in self-reported perceived autonomy
Time frame: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Clemens Tesch-Römer, Prof. Dr. study chair
German Centre of Gerontology
Ralf Schwarzer, Prof. Dr. study chair
Freie Universität Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social-cognitive resource intervention in people with Multimorbidity, run by German Centre of Gerontology at 1 site in Germany.
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 2 inclusion and 1 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 31 Mar 2015. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in physical activity (time frame: Baseline, 6 weeks, 10 weeks, 8.5 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2015.