Trial document





This trial has been registered retrospectively.
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  DRKS00006355

Trial Description

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Title



Telephone-based psychotherapy for family-caregivers of people with dementia - Practice transfer of a telephone-based psychotherapy for supporting family-caregivers

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Trial Acronym

Tele.TAnDem.Tansfer

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URL of the Trial

http://www.teletandem.uni-jena.de/

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Brief Summary in Lay Language

Caregivers are confronted with high demands. This leads to a need for professional support. Simultaneously, the high burden of care can also lead to a situation in which support services cannot be used.
Telephone support can often be used more easily as it can be accessed from home.
Against this background, we want to investigate (1) whether the implementation of a telephone-based therapy in established care structures is realisable, (2) whether the telephone-based therapy is more effective compared to conventional support services, and (3) whether the telephone-based therapy is as effective as face-to-face therapy.
To assess this, family caregivers are interviewed three times 6 months apart. All participants receive information material about care and dementia. The telephone group receives 12 psychotherapy sessions on the phone, the personal-contact group receives 12 psychotherapy sessions in one of the participating treatment centers. Participants are asked whether they reside in the territory of a study center and could participate in the personal therapy. If this is the case, they are assigned to the face-to-face group. If this is not the case, they are randomly assigned to either the telephone group or the control group.
The results of the study will be used to improve support services for caregivers.

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Brief Summary in Scientific Language

Family caregivers are confronted with high demands creating a need for professional support as well as creating barriers for its utilization. Telephone support allows easier access than face-to-face support. The objectives of this study were (1) to test the implementation of a telephone-based cognitive-behavioural therapy (TCT) in established care provision structures, (2) to assess whether TCT improves outcomes compared to usual care, and (3) whether TCT is as effective as face-to-face therapy (FCT).
Family caregivers are interviewed at three measurement points each 6 months apart. All participants receive information materials on care and dementia. The telephone group receives 12 psychotherapy sessions on the phone, the face-to-face group receives 12 psychotherapy sessions in direct contact in one of the treatment centers. Participants are asked whether they reside in the area of a study center and could participate in the FCT. If this is the case, they are assigned to the face-to-face group. If this is not the case, they are randomly assigned to the TCT or the control group.
The following questions are to be examined:
(1) Is the TeleTAnDem intervention more effective than usual care regarding the improvement of subjective health complaints, quality of life and depressiveness?
(2) Is a two-day training (8h) in Tele.TAnDem for trained behavioral therapists sufficient to achieve an adequate and effective implementation of the intervention in a counseling office of the Alzheimer Society?
(3) Is the Tele.TAnDem intervention a cost-effective or possibly even cost-saving alternative compared to usual care?
(4) Is the telephone therapy equally effective as the face-to-face intervention (similar in content and therapeutic procedures)?
(5) Does Tele.TAnDem increase the use of professional support from family-caregivers of people with dementia?
(6) Does Tele.TAnDem lead to delayed institutionalization of people with dementia and thus promote care at home?
The results of the study will be used to improve support services for family-caregivers.

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Organizational Data

  •   DRKS00006355
  •   2014/10/29
  •   [---]*
  •   yes
  •   Approved
  •   3453-05/12, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F03 -  Unspecified dementia
  •   Burden of care
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Interventions/Observational Groups

  •   Telephone-based psychotherapy: Twelve 50-minute sessions are conducted within six months. The first four sessions take place at weekly intervals, further six sessions follow at two-week intervals. The two last sessions are conducted at monthly intervals.
  •   Control group: The control group receives usual care and written information on care/dementia.
  •   Face-to-face psychotherapy: Twelve 50-minute sessions are conducted within six months. The first four sessions take place at weekly intervals, further six sessions follow at two-week intervals. The two last sessions are conducted at monthly intervals.

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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control, No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Depressiveness is assessed at all three time points (T0: baseline; T1: 6 months after baseline (control group) or after the end of the 6-month therapy (intervention groups); T2: 6 months after T1) using a self-developed thermometer scale and the Allgemeine Depressionsskala (ADS).

Burden of care is assessed at all three time points using a self-developed thermometer scale.

Health complaints are assessed at all three time points using the Giessener Beschwerdebogen (GBB-24).

Ability to solve problems relating to the focused problem areas is measured through goal attainment scaling (GAS) in the course of the therapy sessions.

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Secondary Outcome

Anxiety is assessed at all three time points (T0: baseline; T1: 6 months after baseline (control group) or after the end of the 6-month therapy (intervention groups); T2: 6 months after T1) with the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-D).

Quality of life is assessed at all three time points with the WHOQOL-Bref.

Violence in caregiving is assessed at all three time points with the LEANDER questionnaire.

Utilization of professional assistance is assessed at all three time points with an instrument developed in collaboration with the Alzheimer Society Thuringia.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/07/08
  •   270
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

a) Caregiving relative: key responsibility in the care of the person with dementia

b) Person with dementia: diagnosed dementia at least with low grade according to medical diagnosis

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Exclusion Criteria

a) Caregiving relative: ongoing psychotherapeutic treatment; severe physical illness; medically diagnosed psychotic disorder

b) Person with dementia: institutionalised or institutionalisation planned in the next 6 months

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Addresses

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    • Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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    • Helmholtz Zentrum München, Institut für Gesundheitsökonomie und Management im Gesundheitswesen
    • Mr.  Prof. Dr.  Rolf  Holle 
    • Ingolstädter Landstraße 1
    • 85764  Neuherberg
    • Germany
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    • Deutsche Alzheimer Gesellschaft e.V.
    • Ms.  Jansen 
    • Germany
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    •   [---]*
    •   [---]*
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    • Alzheimer Gesellschaft München e.V.
    • Ms.  Broda 
    • Germany
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    •   [---]*
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    • Alzheimer Gesellschaft Thüringen e.V.
    • Ms.  Seidler 
    • Germany
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    •   [---]*
    •   [---]*
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    • Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • Rochusstr. 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.