Caregivers of People With DementiaNCT02806583
Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia
A study testing structured support groups in people with Caregivers of People With Dementia, run by University of Leipzig at 1 site in Germany.
Trial summary
Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers of People With Dementia
- What is being tested?
- structured support groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical ICD-10 dementia diagnosis available for the patient (F00.-*: Alzheimer disease or related disorders, F01.-: Vascular dementia, F03.-:Unspecified dementia)
- living with or sharing cooking facilities with the care recipient or providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours on at least 4 days of a week for at least the past 6 months, respectively
- access to a telephone connection to be able to participate in the talking Time Intervention and the telephone- based interviews for the evaluation
Who cannot join
- lack of knowledge of German Language of informal caregiver
- risk of suicide in the informal caregiver
- actual psychiatric diagnosis of mental illness of the caregiver
- ICD-10-diagnosis of Dementia in other diseases classified elsewhere (F02.-*), except Dementia in Primary Parkinson disease (F02.3*) and Lewy Body disease (F02.8/G31.82)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ICs, relatives either have no time or opportunity to leave the PwD alone or there are no support groups in the vicinity. The Talking Time project therefore aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown resulting benefits for ICs.
Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled trial. The effects of the 3-months Talking Time intervention will be compared to a normal care group. Outcomes will be measured at two different times (baseline = T0, after 3 months =T1). The control group will receive the Talking Time intervention after T1.
Read more
ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on four days per week in the last six months. Exclusion criteria are psychiatric disorders of the IC.
Primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the SF-12. Secondary outcomes are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.
- Conditions
- Caregivers of People With Dementia
- Being tested
- structured support groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured support groupsOther
Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | telephone based structured support groups Receives: Other: structured support groups |
| control | No intervention | Active Comparator: Usual care (intervention as experimental group after 3 month (after T1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)
psychological quality of life of the caregivers
Measured: 3 months
Secondary outcomes (4)
Physical Component Summary of the SF-12
physical quality of life of the caregivers
Measured: 3 months
Perceived Social Support Caregiving Scale
perceived social Support of the caregivers
Measured: 3 months
Caregiver Reaction Scale
caregivers burden
Measured: 3 months
Neuropsychiatric Inventory
neuropsychiatric symptoms of patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startNov 2015
- Primary completion13 Mar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Caregivers of People With DementiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE)
- Responsible party
- Principal investigator, Dr. Martin Berwig, University of Leipzig
- Investigators
- Martin Berwig, Dr., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806583
- Sponsor's protocol ID
- 932 000 - 151
- Status last verified
- Oct 2017
- First submitted
- 9 Jun 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
PubMed 33417236Dichter MN, Albers B, Trutschel D, Strobel AM, Seismann-Petersen S, Wermke K, Halek M, Berwig M. TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone. BMC Health Serv Res. 2020 Aug 25;20(1):788. doi: 10.1186/s12913-020-05523-9.
PubMed 32838773Berwig M, Dichter MN, Albers B, Wermke K, Trutschel D, Seismann-Petersen S, Halek M. Feasibility and effectiveness of a telephone-based social support intervention for informal caregivers of people with dementia: Study protocol of the TALKING TIME project. BMC Health Serv Res. 2017 Apr 17;17(1):280. doi: 10.1186/s12913-017-2231-2.
PubMed 28415999
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking Time: Telephone Support Groups for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02806583
- Acronym / sponsor ID
- 932 000 - 151
- Conditions
- Caregivers of People With Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Center for Neurodegenerative Diseases (DZNE)
- Study start
- Nov 2015
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Jun 2016 (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.
Caring for people with dementia (PwD) at home requires an enormous amount of time, organization and commitment. Therefore, informal caregivers (ICs), mainly relatives, of PwD often feel a high burden. Even though support groups on-site have shown positive effects on the subjective well-being and on the perceived social support of ICs, relatives either have no time or opportunity to leave the PwD alone or there are no support groups in the vicinity. The Talking Time project therefore aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown resulting benefits for ICs.
Methods/Design: The project will be evaluated in a cluster adjusted randomized controlled trial. The effects of the 3-months Talking Time intervention will be compared to a normal care group. Outcomes will be measured at two different times (baseline = T0, after 3 months =T1). The control group will receive the Talking Time intervention after T1.
ICs are eligible if they are 18 or older, have cared for the PwD for at least four hours on four days per week in the last six months. Exclusion criteria are psychiatric disorders of the IC.
Primary outcome of the effectiveness elevation is the subjective well-being of the relatives measured by the mental component of the SF-12. Secondary outcomes are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale, the Caregiver Reaction Scale and the Neuropsychiatric Inventory. For the process evaluation different quantitative and qualitative data sources will be collected addressing reach, fidelity, and dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: structured support groupstelephone based structured support groups |
| control | No intervention | –Active Comparator: Usual care (intervention as experimental group after 3 month (after T1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medical ICD-10 dementia diagnosis available for the patient (F00.-*: Alzheimer disease or related disorders, F01.-: Vascular dementia, F03.-:Unspecified dementia)
- living with or sharing cooking facilities with the care recipient or providing care for a relative with diagnosed Alzheimer disease or related disorders for at least 4 hours on at least 4 days of a week for at least the past 6 months, respectively
- access to a telephone connection to be able to participate in the talking Time Intervention and the telephone- based interviews for the evaluation
Key exclusion criteria (4 listed)
- lack of knowledge of German Language of informal caregiver
- risk of suicide in the informal caregiver
- actual psychiatric diagnosis of mental illness of the caregiver
- ICD-10-diagnosis of Dementia in other diseases classified elsewhere (F02.-*), except Dementia in Primary Parkinson disease (F02.3*) and Lewy Body disease (F02.8/G31.82)
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 |
|---|---|---|
| structured support groupsTelephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups | Other | intervention |
Primary outcome
Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12)
Time frame: 3 months
psychological quality of life of the caregivers
4 secondary outcomes
Physical Component Summary of the SF-12
Time frame: 3 months
Perceived Social Support Caregiving Scale
Time frame: 3 months
Caregiver Reaction Scale
Time frame: 3 months
Neuropsychiatric Inventory
Time frame: 3 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 9 Oct 2017.
- Derived from this study: PubMed 33417236Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
- Derived from this study: PubMed 32838773Dichter MN, Albers B, Trutschel D, Strobel AM, Seismann-Petersen S, Wermke K, Halek M, Berwig M. TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone. BMC Health Serv Res. 2020 Aug 25;20(1):788. doi: 10.1186/s12913-020-05523-9.
- Derived from this study: PubMed 28415999Berwig M, Dichter MN, Albers B, Wermke K, Trutschel D, Seismann-Petersen S, Halek M. Feasibility and effectiveness of a telephone-based social support intervention for informal caregivers of people with dementia: Study protocol of the TALKING TIME project. BMC Health Serv Res. 2017 Apr 17;17(1):280. doi: 10.1186/s12913-017-2231-2.
- Individual participant dataSharing planned: No
Related trials for Caregivers of People With Dementia
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
RecruitingPhase 2
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
Stress
Recruiting
Buddy-Up Dyadic Physical Activity Program for Persons With Dementia and Family Caregivers
Cognitive Impairment, Mild, Dementia, Mild
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
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.
Martin Berwig, Dr. principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured support groups in people with Caregivers of People With Dementia, run by University of Leipzig 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 3 inclusion and 4 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 9 Oct 2017. 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?
Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (time frame: 3 months). 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 NCT02806583, which also lists 3 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 9 Oct 2017.